STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
This device is manufactured by MDT PUERTO RICO OPERATIONS CO MED REL, MDT SOFAMOR DANEK PUERTO RICO MFG, MED REL HUMACAO, MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO OPERATIONS MED-REL, MEDTRONIC SA (SMO).
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-26 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-05-06 | Malfunction | Inflammation, Insufficient Information | Battery Problem |
| 2024-05-02 | Injury | Seroma | Adverse Event Without Identified Device or Use Problem |
| 2023-12-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-11-02 | Injury | Hypersensitivity/Allergic reaction | Adverse Event Without Identified Device or Use Problem |
| 2023-11-02 | Injury | Cramp(s) /Muscle Spasm(s), Insufficient Information | Failure to Deliver Energy, Energy Output Problem, Therapy Delivered to Incorrect Body Area, Malposition of Device, Device Operates Differently Than Expected |
| 2023-10-26 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Malposition of Device |
| 2023-03-10 | Injury | No Clinical Signs, Symptoms or Conditions | Battery Problem, Insufficient Information |
| 2023-01-27 | Injury | No Clinical Signs, Symptoms or Conditions | Insufficient Information |
| 2022-10-11 | Injury | None | Positioning Problem |
| 2022-06-07 | Malfunction | None | Break, Difficult to Remove |
| 2022-03-29 | Injury | None | High impedance |
| 2021-09-15 | Injury | None | Break, High impedance |
| 2020-10-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2020-10-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2020-10-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-09-23 | Malfunction | None | Insufficient Information |
| 2019-09-18 | Malfunction | None | Insufficient Information |
| 2019-09-13 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-09-09 | Injury | None | Break |
| 2019-09-03 | Injury | None | Break |
| 2019-09-03 | Injury | None | Migration or Expulsion of Device |
| 2019-08-28 | Injury | None | Battery Problem |
| 2019-08-27 | Malfunction | None | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2019-08-27 | Injury | None | Battery Problem, Insufficient Information |
| 2019-08-23 | Malfunction | None | Break, High impedance |
| 2019-08-16 | Injury | None | Insufficient Information |
| 2019-08-09 | Injury | None | Insufficient Information |
| 2019-08-03 | Injury | None | None |
| 2019-07-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-25 | Injury | None | Break |
| 2019-07-16 | Injury | None | Insufficient Information |
| 2019-07-12 | Injury | None | Insufficient Information |
| 2019-07-05 | Malfunction | None | Failure to Deliver Energy, Insufficient Information |
| 2019-07-02 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation, Adverse Event Without Identified Device or Use Problem |
| 2019-06-24 | Injury | None | Insufficient Information |
| 2019-06-12 | Injury | None | Electromagnetic Interference, Energy Output Problem |
| 2019-06-11 | Injury | None | Intermittent Continuity, Electromagnetic Interference, Failure to Deliver Energy, Battery Problem |
| 2019-06-01 | Malfunction | None | Energy Output Problem |
| 2019-05-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-03 | Malfunction | None | Electromagnetic Interference, Failure to Deliver Energy, Battery Problem |
| 2019-04-29 | Injury | None | Insufficient Information |
| 2019-04-26 | Injury | None | Insufficient Information |
| 2019-04-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-15 | Malfunction | None | None |
| 2019-04-09 | Malfunction | None | Insufficient Information |
| 2019-03-27 | Injury | None | Intermittent Continuity, Failure to Deliver Energy |
| 2019-03-27 | Injury | None | Migration or Expulsion of Device, Battery Problem, Insufficient Information |
| 2019-03-26 | Malfunction | None | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2019-03-21 | Injury | None | Break |
| 2019-03-18 | Malfunction | None | High impedance, Energy Output Problem, Insufficient Information |
| 2019-03-08 | Malfunction | None | Insufficient Information |
| 2019-03-08 | Malfunction | None | Insufficient Information |
| 2019-02-28 | Malfunction | None | Insufficient Information |
| 2019-02-17 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation, Battery Problem |
| 2019-02-14 | Malfunction | None | Energy Output Problem, Overheating of Device, Battery Problem |
| 2019-02-14 | Malfunction | None | Insufficient Information |
| 2019-02-07 | Injury | None | Break, Energy Output Problem, Device Operates Differently Than Expected, Patient Device Interaction Problem |
| 2019-02-07 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-28 | Malfunction | None | Malposition of Device |
| 2019-01-06 | Malfunction | None | Failure to Deliver Energy, No Device Output |
| 2019-01-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-04 | Injury | None | Break, Peeled/Delaminated, Battery Problem |
| 2018-12-18 | Injury | None | None |
| 2018-12-17 | Injury | None | Migration or Expulsion of Device, Malposition of Device |
| 2018-12-12 | Malfunction | None | Premature Discharge of Battery, Failure to Deliver Energy |
| 2018-12-10 | Malfunction | None | High impedance |
| 2018-12-08 | Injury | None | Insufficient Information |
| 2018-12-05 | Injury | None | Failure to Deliver Energy, Peeled/Delaminated, Malposition of Device, Insufficient Information |
| 2018-12-05 | Malfunction | None | Difficult to Insert, Difficult to Remove, Insufficient Information |
| 2018-12-03 | Malfunction | None | Insufficient Information |
| 2018-11-27 | Malfunction | None | Insufficient Information |
| 2018-11-27 | Malfunction | None | Migration or Expulsion of Device, Unintended Collision, Insufficient Information |
| 2018-11-15 | Malfunction | None | Insufficient Information |
| 2018-11-12 | Malfunction | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation |
| 2018-11-08 | Malfunction | None | High impedance |
| 2018-11-08 | Injury | None | Failure to Deliver Energy |
| 2018-11-07 | Injury | None | Break |
| 2018-11-04 | Malfunction | None | Failure to Deliver Energy, Energy Output Problem |
| 2018-11-01 | Malfunction | None | Battery Problem, Electromagnetic Compatibility Problem, Insufficient Information |
| 2018-10-29 | Malfunction | None | Insufficient Information |
| 2018-10-18 | Malfunction | None | Insufficient Information |
| 2018-10-18 | Malfunction | None | Break, Difficult to Remove, Adverse Event Without Identified Device or Use Problem |
| 2018-10-05 | Injury | None | Migration or Expulsion of Device, Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2018-10-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-05 | Injury | None | Insufficient Information, Appropriate Term/Code Not Available |
| 2018-10-04 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2018-10-04 | Injury | None | Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available |
| 2018-10-04 | Malfunction | None | Mechanical Problem, Insufficient Information |
| 2018-10-02 | Malfunction | None | Energy Output Problem, Application Program Problem, Battery Problem, Battery Problem: Low Impedance |
| 2018-10-02 | Malfunction | None | Intermittent Continuity, Inappropriate/Inadequate Shock/Stimulation, Data Problem |
| 2018-09-26 | Injury | None | Insufficient Information |
| 2018-09-17 | Malfunction | None | Break, Detachment of Device or Device Component |
| 2018-09-07 | Injury | None | Insufficient Information |
| 2018-08-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-07 | Malfunction | None | Failure to Deliver Energy, Unintended Collision, Insufficient Information |
| 2018-08-03 | Injury | None | Energy Output Problem, Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available |
| 2018-08-03 | Malfunction | None | Energy Output Problem, Patient Device Interaction Problem |
| 2018-07-31 | Malfunction | None | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2018-07-24 | Malfunction | None | Premature Discharge of Battery, Electromagnetic Interference, Failure to Interrogate, Energy Output Problem, No Device Output, Communication or Transmission Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-07-18 | Injury | None | Break, Material Deformation, Adverse Event Without Identified Device or Use Problem |
| 2018-07-03 | Injury | None | Break, Malposition of Device, Device Operates Differently Than Expected |
| 2018-07-03 | Injury | None | Break, Malposition of Device |
| 2018-06-29 | Malfunction | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation |
| 2018-06-19 | Malfunction | None | Failure to Interrogate, Device Or Device Fragments Location Unknown, Communication or Transmission Problem, Device Operates Differently Than Expected |
| 2018-06-18 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2018-06-13 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2018-06-13 | Injury | None | Break, Device Or Device Fragments Location Unknown |
| 2018-05-31 | Injury | None | High impedance, Unintended Collision, Impedance Problem |
| 2018-05-28 | Injury | None | Overheating of Device |
| 2018-05-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-24 | Injury | None | Device Operates Differently Than Expected |
| 2018-04-18 | Injury | None | Device Operates Differently Than Expected, Insufficient Information |
| 2018-04-12 | Injury | None | Break, High impedance, Connection Problem, Material Deformation |
| 2018-04-07 | Malfunction | None | Failure to Interrogate, Low Battery, Communication or Transmission Problem |
| 2018-04-07 | Malfunction | None | Failure to Interrogate, Low Battery, Communication or Transmission Problem |
| 2018-04-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-04-03 | Malfunction | None | Failure to Deliver Energy, Failure to Interrogate, No Device Output, Device Displays Incorrect Message, Communication or Transmission Problem |
| 2018-04-01 | Injury | None | Failure to Deliver Energy, Therapy Delivered to Incorrect Body Area |
| 2018-04-01 | Injury | None | Battery Problem, Appropriate Term/Code Not Available |
| 2018-04-01 | Injury | Device Embedded In Tissue or Plaque, No Clinical Signs, Symptoms or Conditions | Break, Degraded, Difficult to Remove, Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem, Impedance Problem, Insufficient Information |
| 2018-03-27 | Injury | None | Device Operates Differently Than Expected |
| 2018-03-15 | Injury | None | Failure to Deliver Energy, Low Battery, Battery Problem, Electromagnetic Compatibility Problem, Insufficient Information |
| 2018-03-14 | Injury | None | Migration or Expulsion of Device, Adverse Event Without Identified Device or Use Problem |
| 2018-03-12 | Malfunction | None | Electromagnetic Interference, Battery Problem |
| 2018-03-09 | Injury | None | Inadequacy of Device Shape and/or Size, Device Operates Differently Than Expected |
| 2018-03-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-02-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-20 | Injury | None | None |
| 2018-02-14 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2018-02-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-02-01 | Malfunction | None | Migration or Expulsion of Device |
| 2018-02-01 | Malfunction | None | Unintended Collision, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2018-02-01 | Injury | None | Device Operates Differently Than Expected |
| 2018-02-01 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2018-01-31 | Injury | None | Device Operates Differently Than Expected |
| 2018-01-29 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-01-24 | Malfunction | None | Intermittent Continuity, Device Operates Differently Than Expected |
| 2018-01-23 | Injury | None | Premature Discharge of Battery |
| 2018-01-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-16 | Injury | None | Device Operates Differently Than Expected |
| 2018-01-10 | Malfunction | None | Device Inoperable |
| 2018-01-09 | Injury | None | Low Battery |
| 2018-01-08 | Injury | None | Device Operates Differently Than Expected |
| 2018-01-03 | Injury | None | High impedance, Impedance Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Injury | None | Insufficient Information |
| 2018-01-01 | Malfunction | None | Failure to Deliver Energy, Loss of Power, Insufficient Information |
| 2017-12-28 | Injury | None | Device Operates Differently Than Expected |
| 2017-12-22 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-12-19 | Injury | None | High impedance, Malposition of Device |
| 2017-12-18 | Injury | None | Migration or Expulsion of Device, Device Operates Differently Than Expected |
| 2017-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-04 | Injury | None | Break, Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2017-12-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-11-30 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-11-29 | Injury | None | Failure to Deliver Energy, Device Operates Differently Than Expected |
| 2017-11-28 | Malfunction | None | Failure to Deliver Energy, Device Operates Differently Than Expected |
| 2017-11-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-27 | Malfunction | None | Intermittent Continuity, Failure to Deliver Energy |
| 2017-11-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-20 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2017-11-16 | Injury | None | High impedance |
| 2017-11-16 | Injury | None | Malposition of Device, Positioning Problem |
| 2017-11-13 | Injury | None | Low impedance, Device Operates Differently Than Expected |
| 2017-11-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-11-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-11-09 | Injury | None | Device Operates Differently Than Expected |
| 2017-11-08 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-07 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2017-11-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-12 | Injury | None | Therapy Delivered to Incorrect Body Area, Low Battery, Adverse Event Without Identified Device or Use Problem |
| 2017-10-11 | Injury | None | Failure to Deliver Energy, Device Operates Differently Than Expected |
| 2017-10-10 | Injury | None | Inadequacy of Device Shape and/or Size |
| 2017-10-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-09-19 | Injury | None | None |
| 2017-09-17 | Malfunction | None | No Device Output, Low Battery, Electromagnetic Compatibility Problem |
| 2017-09-14 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-09-05 | Malfunction | None | Failure to Deliver Energy, Low Battery, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-09-02 | Malfunction | None | Electromagnetic Interference, Device Operates Differently Than Expected |
| 2017-09-01 | Injury | None | Break, Migration or Expulsion of Device |
| 2017-08-30 | Injury | None | Device Operates Differently Than Expected, Device Contamination with Chemical or Other Material |
| 2017-08-29 | Malfunction | None | Migration or Expulsion of Device, Overheating of Device, Device Operates Differently Than Expected |
| 2017-08-25 | Malfunction | None | Low Battery, Device Displays Incorrect Message |
| 2017-08-21 | Malfunction | None | Leak/Splash, Electronic Property Issue |
| 2017-08-21 | Malfunction | None | Break |
| 2017-08-18 | Malfunction | None | Migration or Expulsion of Device, Device Operates Differently Than Expected |
| 2017-08-16 | Injury | None | Device Operates Differently Than Expected |
| 2017-08-11 | Injury | None | Failure to Deliver Energy |
| 2017-08-03 | Injury | None | Break, Failure to Deliver Energy, High impedance, Unintended Collision, Overheating of Device, Inappropriate/Inadequate Shock/Stimulation |
| 2017-07-31 | Injury | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation, Device Or Device Fragments Location Unknown |
| 2017-07-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-14 | Injury | None | Low Battery, Device Operates Differently Than Expected |
| 2017-07-10 | Malfunction | None | Therapy Delivered to Incorrect Body Area, Device Operates Differently Than Expected, Electromagnetic Compatibility Problem |
| 2017-06-30 | Malfunction | None | Unintended Collision, Device Operates Differently Than Expected |
| 2017-06-29 | Malfunction | None | Electromagnetic Interference, Low Battery, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-06-28 | Malfunction | None | Therapy Delivered to Incorrect Body Area, Inappropriate/Inadequate Shock/Stimulation, Low Battery |
| 2017-06-26 | Malfunction | None | Unintended Collision, Device Operates Differently Than Expected |
| 2017-06-22 | Injury | None | Break, Material Deformation, Adverse Event Without Identified Device or Use Problem |
| 2017-06-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-05 | Malfunction | None | Device Or Device Fragments Location Unknown |
| 2017-06-02 | Injury | None | Intermittent Continuity, Device Operates Differently Than Expected |
| 2017-05-31 | Malfunction | None | Break, Device Or Device Fragments Location Unknown |
| 2017-05-31 | Injury | None | Break, High impedance, Device Or Device Fragments Location Unknown |
| 2017-05-30 | Injury | None | Unintended Collision, Device Operates Differently Than Expected |
| 2017-05-30 | Injury | None | Device Operates Differently Than Expected |
| 2017-05-26 | Injury | None | Device Operates Differently Than Expected |
| 2017-05-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-16 | Malfunction | None | Failure to Deliver Energy, Failure to Interrogate, Device Displays Incorrect Message, Communication or Transmission Problem |
| 2017-05-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-10 | Injury | None | Migration or Expulsion of Device, Environmental Compatibility Problem |
| 2017-05-02 | Injury | None | Intermittent Continuity, Migration or Expulsion of Device, Device Displays Incorrect Message |
| 2017-04-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-27 | Injury | None | Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2017-04-24 | Malfunction | None | Break |
| 2017-04-19 | Malfunction | None | Improper Device Output |
| 2017-04-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-07 | Malfunction | None | Premature Discharge of Battery |
| 2017-04-05 | Malfunction | None | Impedance Problem |
| 2017-04-05 | Injury | None | Failure to Interrogate, Communication or Transmission Problem |
| 2017-04-05 | Malfunction | None | Impedance Problem |
| 2017-04-01 | Injury | None | Unintended Collision, Device Operates Differently Than Expected |
| 2017-03-29 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2017-03-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-15 | Injury | None | None |
| 2017-03-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-07 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-03-04 | Malfunction | None | Intermittent Continuity, Failure to Deliver Energy, Device Operates Differently Than Expected |
| 2017-03-01 | Malfunction | None | Pocket Stimulation, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2017-02-25 | Malfunction | None | Migration or Expulsion of Device, Adverse Event Without Identified Device or Use Problem |
| 2017-02-22 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-16 | Malfunction | None | Electromagnetic Compatibility Problem, Environmental Compatibility Problem |
| 2017-02-13 | Malfunction | None | Peeled/Delaminated |
| 2017-02-09 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2017-02-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-05 | Injury | None | Break, Therapy Delivered to Incorrect Body Area, Device Operates Differently Than Expected |
| 2017-02-05 | Malfunction | None | Low Battery, Device Displays Incorrect Message |
| 2017-02-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-01 | Injury | None | Failure to Deliver Energy, Failure to Interrogate, Unintended Collision, Device Displays Incorrect Message, Communication or Transmission Problem, Device Operates Differently Than Expected |
| 2017-01-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-30 | Injury | None | High impedance, Migration or Expulsion of Device, Pocket Stimulation, Inappropriate/Inadequate Shock/Stimulation, Unstable |
| 2017-01-30 | Injury | None | Migration or Expulsion of Device, Device Operates Differently Than Expected |
| 2017-01-27 | Injury | None | Break, Device Or Device Fragments Location Unknown |
| 2017-01-25 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-11 | Malfunction | None | None |
| 2017-01-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-10 | Injury | None | Break, Migration or Expulsion of Device, Nonstandard Device, Device Slipped |
| 2017-01-09 | Injury | None | Unintended Collision, Inappropriate/Inadequate Shock/Stimulation |
| 2017-01-09 | Injury | None | None |
| 2017-01-07 | Injury | None | Failure to Deliver Energy, High impedance |
| 2017-01-06 | Injury | None | None |
| 2017-01-05 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2017-01-05 | Malfunction | None | Intermittent Continuity, Device Operates Differently Than Expected |
| 2017-01-01 | Malfunction | None | Premature Discharge of Battery, Low Battery, Device Displays Incorrect Message |
| 2017-01-01 | Injury | None | Failure to Deliver Energy, Communication or Transmission Problem, Device Operates Differently Than Expected, Environmental Compatibility Problem, Insufficient Information |
| 2016-12-31 | Malfunction | None | No Device Output, Device Operates Differently Than Expected |
| 2016-12-22 | Injury | None | Unintended Collision, Device Operates Differently Than Expected |
| 2016-12-19 | Malfunction | None | Labelling, Instructions for Use or Training Problem, Device Operates Differently Than Expected |
| 2016-12-10 | Injury | None | Energy Output To Patient Tissue Incorrect, Low Battery, Device Operates Differently Than Expected |
| 2016-12-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-05 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2016-12-05 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2016-12-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-01 | Injury | None | Low Battery, Device Or Device Fragments Location Unknown |
| 2016-12-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2016-12-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-24 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2016-11-22 | Injury | None | Device Operates Differently Than Expected |
| 2016-11-17 | Injury | None | Break, Unintended Collision, Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2016-11-11 | Injury | None | Device Operates Differently Than Expected |
| 2016-11-08 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2016-11-03 | Malfunction | None | Electromagnetic Interference, Failure to Deliver Energy, Device Operates Differently Than Expected |
| 2016-10-27 | Injury | None | Premature Discharge of Battery |
| 2016-10-20 | Injury | None | Device Or Device Fragments Location Unknown |
| 2016-10-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-19 | Malfunction | None | Device Displays Incorrect Message, Electromagnetic Compatibility Problem |
| 2016-10-18 | Injury | None | Device Operates Differently Than Expected |
| 2016-10-12 | Malfunction | None | High impedance, Peeled/Delaminated, Connection Problem |
| 2016-10-07 | Injury | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2016-10-05 | Injury | None | Unintended Collision, Low Battery |
| 2016-10-05 | Injury | None | Failure to Interrogate, Low Battery, Communication or Transmission Problem, Device Operates Differently Than Expected |
| 2016-10-05 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-29 | Injury | None | Device Operates Differently Than Expected |
| 2016-09-29 | Malfunction | None | Unintended Collision, Device Operates Differently Than Expected |
| 2016-09-27 | Malfunction | None | High impedance, Low impedance |
| 2016-09-21 | Malfunction | None | Failure to Deliver Energy, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2016-09-19 | Malfunction | None | Failure to Interrogate, Communication or Transmission Problem, Device Operates Differently Than Expected |
| 2016-09-16 | Malfunction | None | Intermittent Continuity, Failure to Interrogate, Low Battery, Communication or Transmission Problem |
| 2016-09-11 | Injury | None | Break, Intermittent Continuity, Failure to Deliver Energy, High impedance, Unintended Collision, Peeled/Delaminated, Stretched, Device Operates Differently Than Expected |
| 2016-09-02 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation, Low impedance, Device Operates Differently Than Expected, Electromagnetic Compatibility Problem |
| 2016-09-01 | Malfunction | None | Unintended Collision |
| 2016-09-01 | Injury | None | Device Operates Differently Than Expected |
| 2016-09-01 | Injury | None | Failure to Deliver Energy, Battery Problem |
| 2016-08-31 | Injury | None | Connection Problem, Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2016-08-30 | Injury | None | Device Operates Differently Than Expected, Insufficient Information |
| 2016-08-23 | Injury | None | Break, Device Or Device Fragments Location Unknown |
| 2016-08-17 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2016-08-14 | Malfunction | None | Migration or Expulsion of Device, Device Operates Differently Than Expected |
| 2016-08-12 | Malfunction | None | Failure to Deliver Energy |
| 2016-08-09 | Malfunction | None | Therapy Delivered to Incorrect Body Area, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2016-08-05 | Malfunction | None | Break, Device Operates Differently Than Expected |
| 2016-08-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-02 | Injury | None | Premature Discharge of Battery, Device Operates Differently Than Expected |
| 2016-08-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-26 | Injury | None | Break |
| 2016-07-26 | Malfunction | None | Shipping Damage or Problem |
| 2016-07-20 | Injury | None | Connection Problem |
| 2016-07-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-05 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-01 | Malfunction | None | Intermittent Continuity, Failure to Deliver Energy, Pocket Stimulation, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2016-07-01 | Injury | None | Failure to Deliver Energy, High impedance, Unintended Collision, Pocket Stimulation |
| 2016-06-28 | Malfunction | None | Break |
| 2016-06-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-01 | Malfunction | None | Failure to Deliver Energy |
| 2016-06-01 | Injury | None | Break, Failure to Deliver Energy, Device Operates Differently Than Expected, Insufficient Information |
| 2016-05-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-05-19 | Injury | None | Intermittent Continuity, Failure to Deliver Energy, Device Operates Differently Than Expected, Electromagnetic Compatibility Problem |
| 2016-05-09 | Injury | None | None |
| 2016-05-05 | Malfunction | None | Unintended Collision, Device Operates Differently Than Expected |
| 2016-05-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2016-04-28 | Malfunction | None | Break, Device Or Device Fragments Location Unknown |
| 2016-04-12 | Injury | None | None |
| 2016-04-01 | Injury | None | Failure to Interrogate, Therapy Delivered to Incorrect Body Area, Inappropriate/Inadequate Shock/Stimulation, Low impedance, Low Battery, Device Displays Incorrect Message, Communication or Transmission Problem, Device Operates Differently Than Expected |
| 2016-03-13 | Malfunction | None | Failure to Deliver Energy, Device Operates Differently Than Expected |
| 2016-03-01 | Malfunction | None | Migration or Expulsion of Device, Unintended Collision |
| 2016-02-13 | Injury | None | Break, Inappropriate/Inadequate Shock/Stimulation |
| 2016-02-12 | Malfunction | None | Impedance Problem |
| 2016-02-01 | Malfunction | None | Failure to Deliver Energy, Electromagnetic Compatibility Problem |
| 2016-01-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-01-01 | Injury | None | Low Battery, Device Displays Incorrect Message, Battery Problem |
| 2016-01-01 | Injury | None | Electromagnetic Compatibility Problem |
| 2016-01-01 | Injury | None | Break, Inappropriate/Inadequate Shock/Stimulation, Positioning Problem |
| 2016-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-11-19 | Injury | None | Break, High impedance, Device Operates Differently Than Expected |
| 2015-11-01 | Injury | None | Intermittent Continuity, Failure to Deliver Energy, Low Battery, Device Displays Incorrect Message, Electromagnetic Compatibility Problem |
| 2015-11-01 | Injury | None | Break, Electromagnetic Compatibility Problem |
| 2015-10-01 | Injury | None | Break, Device Or Device Fragments Location Unknown, Adverse Event Without Identified Device or Use Problem |
| 2015-09-15 | Malfunction | None | Break |
| 2015-09-11 | Injury | None | Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available |
| 2015-07-01 | Malfunction | None | Failure to Deliver Energy, High impedance, Migration or Expulsion of Device, Insufficient Information |
| 2015-06-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-05-20 | Injury | None | Migration or Expulsion of Device |
| 2015-05-12 | Injury | None | Electromagnetic Interference |
| 2015-05-08 | Injury | None | Device Operates Differently Than Expected |
| 2015-05-08 | Injury | None | Break, Failure to Deliver Energy, High impedance, Unable to Obtain Readings, Difficult to Remove, Low impedance, Device Or Device Fragments Location Unknown |
| 2015-05-06 | Injury | None | Malposition of Device, Device Operates Differently Than Expected |
| 2015-05-06 | Injury | None | Migration or Expulsion of Device |
| 2015-05-06 | Malfunction | None | Electromagnetic Interference, Failure to Deliver Energy, Device Operates Differently Than Expected |
| 2015-05-06 | Injury | None | Failure to Interrogate, Communication or Transmission Problem |
| 2015-05-04 | Injury | None | Break |
| 2015-05-02 | Malfunction | None | Failure to Deliver Energy, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2015-05-01 | Injury | None | Device Operates Differently Than Expected |
| 2015-04-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-04-28 | Injury | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2015-04-27 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Electromagnetic Compatibility Problem |
| 2015-04-23 | Injury | None | Device Operates Differently Than Expected |
| 2015-04-23 | Malfunction | None | Migration or Expulsion of Device |
| 2015-04-22 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-04-21 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2015-04-17 | Injury | None | Failure to Deliver Energy |
| 2015-04-16 | Malfunction | None | Therapy Delivered to Incorrect Body Area, Inappropriate/Inadequate Shock/Stimulation, Improper Device Output |
| 2015-04-14 | Injury | None | Unintended Collision, Battery Problem, Device Operates Differently Than Expected |
| 2015-04-13 | Malfunction | None | Migration or Expulsion of Device, Device Operates Differently Than Expected |
| 2015-04-10 | Injury | None | Break, Difficult to Remove, Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected, Impedance Problem |
| 2015-04-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-04-10 | Injury | None | Device Operates Differently Than Expected |
| 2015-04-03 | Malfunction | None | Degraded, Device Contamination with Chemical or Other Material |
| 2015-04-03 | Malfunction | None | Device Operates Differently Than Expected, Electromagnetic Compatibility Problem |
| 2015-04-02 | Injury | None | Electromagnetic Interference, Energy Output To Patient Tissue Incorrect, Migration or Expulsion of Device, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2015-04-02 | Injury | None | Electromagnetic Interference, Energy Output To Patient Tissue Incorrect, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2015-04-02 | Injury | None | Electromagnetic Interference, Energy Output To Patient Tissue Incorrect, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2015-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-04-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-03-30 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2015-03-30 | Injury | None | Break, Unintended Collision, Impedance Problem |
| 2015-03-27 | Injury | None | Low Readings, Device Operates Differently Than Expected |
| 2015-03-26 | Malfunction | None | Intermittent Continuity |
| 2015-03-25 | Malfunction | None | Intermittent Continuity, Failure to Deliver Energy, Migration or Expulsion of Device, Device Operates Differently Than Expected |
| 2015-03-20 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Unexpected Therapeutic Results |
| 2015-02-27 | Injury | None | Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2015-01-01 | Injury | None | Failure to Power Up, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2015-01-01 | Malfunction | None | Electromagnetic Compatibility Problem |
| 2015-01-01 | Injury | None | Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2015-01-01 | Injury | None | Overheating of Device, Device Operates Differently Than Expected |
| 2015-01-01 | Injury | None | Device Operates Differently Than Expected |
| 2014-12-17 | Injury | None | Break, Detachment Of Device Component, Material Fragmentation |
| 2014-12-01 | Injury | None | Battery Problem, Adverse Event Without Identified Device or Use Problem |
| 2014-11-21 | Injury | None | Disconnection |
| 2014-11-03 | Injury | None | Migration or Expulsion of Device |
| 2014-10-14 | Injury | None | Device Operates Differently Than Expected |
| 2014-10-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-09-26 | Injury | None | Failure to Deliver Energy, Unintended Collision |
| 2014-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-07-29 | Injury | None | Unintended Collision |
| 2014-07-29 | Injury | None | Unexpected Therapeutic Results, Device Operates Differently Than Expected |
| 2014-07-25 | Injury | None | Premature Discharge of Battery, Unintended Collision, Device Operates Differently Than Expected |
| 2014-07-24 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-07-24 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Displays Incorrect Message, Electromagnetic Compatibility Problem |
| 2014-07-22 | Injury | None | Failure to Deliver Energy |
| 2014-07-22 | Malfunction | None | Malposition of Device, Device Operates Differently Than Expected |
| 2014-07-21 | Injury | None | Migration or Expulsion of Device |
| 2014-07-20 | Malfunction | None | Failure to Deliver Energy |
| 2014-07-16 | Injury | None | Unexpected Therapeutic Results, Malposition of Device |
| 2014-07-11 | Injury | None | Migration or Expulsion of Device, Unintended Collision |
| 2014-07-09 | Malfunction | None | Intermittent Continuity, Failure to Deliver Energy |
| 2014-07-07 | Injury | None | Failure to Deliver Energy, Battery Problem |
| 2014-07-05 | Injury | None | Device Operates Differently Than Expected |
| 2014-07-04 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation, Malposition of Device |
| 2014-07-02 | Injury | None | Device Operates Differently Than Expected |
| 2014-07-02 | Injury | None | Migration or Expulsion of Device, Low Battery |
| 2014-07-01 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2014-06-30 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2014-06-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-27 | Injury | None | Failure to Deliver Energy, Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2014-06-26 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2014-06-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-06-23 | Injury | None | Device Operates Differently Than Expected |
| 2014-06-21 | Malfunction | None | Break, Material Deformation |
| 2014-06-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-20 | Injury | None | Failure to Deliver Energy, Malposition of Device, Device Operates Differently Than Expected |
| 2014-06-19 | Injury | None | Break, Therapy Delivered to Incorrect Body Area |
| 2014-06-19 | Injury | None | Break, Device Or Device Fragments Location Unknown, Malposition of Device |
| 2014-06-19 | Injury | None | Break, Therapy Delivered to Incorrect Body Area |
| 2014-06-18 | Injury | None | Migration or Expulsion of Device, Unintended Collision |
| 2014-06-17 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2014-06-13 | Injury | None | None |
| 2014-06-11 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-06-11 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-06-11 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-06-11 | Injury | None | Break |
| 2014-06-05 | Injury | None | Device Displays Incorrect Message, Device Operates Differently Than Expected, Electromagnetic Compatibility Problem |
| 2014-06-04 | Injury | None | Break, Low Battery |
| 2014-06-04 | Malfunction | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation |
| 2014-06-04 | Injury | None | Low Battery, Device Operates Differently Than Expected |
| 2014-06-04 | Injury | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation |
| 2014-06-03 | Injury | None | Migration or Expulsion of Device, Electromagnetic Compatibility Problem |
| 2014-05-28 | Injury | None | Break, Low Battery, Malposition of Device, Device Operates Differently Than Expected |
| 2014-05-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-05-22 | Injury | None | Device Operates Differently Than Expected |
| 2014-05-22 | Injury | None | Electromagnetic Interference, Device Operates Differently Than Expected |
| 2014-05-20 | Injury | None | Failure to Interrogate, Battery Problem, Communication or Transmission Problem, Device Operates Differently Than Expected |
| 2014-05-19 | Malfunction | None | Low impedance, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2014-05-15 | Injury | None | Break, Peeled/Delaminated |
| 2014-05-13 | Malfunction | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation |
| 2014-05-13 | Malfunction | None | Shelf Life Exceeded |
| 2014-05-09 | Malfunction | None | Failure to Deliver Energy, Device Operates Differently Than Expected |
| 2014-05-07 | Injury | None | Failure to Deliver Energy, Communication or Transmission Problem |
| 2014-05-07 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-05-07 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-05-05 | Injury | None | Migration or Expulsion of Device, Positioning Problem |
| 2014-05-05 | Malfunction | None | Intermittent Continuity, Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation |
| 2014-05-05 | Malfunction | None | Migration or Expulsion of Device |
| 2014-05-05 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-05-01 | Injury | None | Electromagnetic Compatibility Problem, Noise, Audible |
| 2014-05-01 | Malfunction | None | Device Displays Incorrect Message |
| 2014-04-30 | Injury | None | Malposition of Device |
| 2014-04-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-04-28 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-04-24 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-04-24 | Malfunction | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation, Compatibility Problem |
| 2014-04-23 | Malfunction | None | Migration or Expulsion of Device |
| 2014-04-21 | Injury | None | Device Or Device Fragments Location Unknown |
| 2014-04-21 | Injury | None | Device Operates Differently Than Expected |
| 2014-04-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-04-16 | Injury | None | Device Displays Incorrect Message |
| 2014-04-14 | Malfunction | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation |
| 2014-04-14 | Malfunction | None | Intermittent Continuity |
| 2014-04-10 | Injury | None | Failure to Interrogate, Communication or Transmission Problem |
| 2014-04-07 | Injury | None | Device Operates Differently Than Expected |
| 2014-04-07 | Injury | None | Material Frayed, Device Dislodged or Dislocated |
| 2014-04-03 | Injury | None | Migration or Expulsion of Device, Therapy Delivered to Incorrect Body Area |
| 2014-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-04-01 | Injury | None | Migration or Expulsion of Device |
| 2014-04-01 | Malfunction | None | Low impedance, Malposition of Device |
| 2014-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-04-01 | Injury | None | Break |
| 2014-04-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-03-31 | Malfunction | None | High impedance |
| 2014-03-31 | Malfunction | None | Overheating of Device, Device Or Device Fragments Location Unknown |
| 2014-03-28 | Malfunction | None | Break |
| 2014-03-27 | Malfunction | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation |
| 2014-03-27 | Malfunction | None | Therapy Delivered to Incorrect Body Area, Electromagnetic Compatibility Problem |
| 2014-03-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-03-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-03-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-03-19 | Injury | None | Break, Intermittent Continuity, Failure to Deliver Energy, High impedance, Device Or Device Fragments Location Unknown |
| 2014-03-18 | Injury | None | Break, Low Battery, Device Or Device Fragments Location Unknown |
| 2014-03-18 | Malfunction | None | Therapy Delivered to Incorrect Body Area, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2014-03-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-03-12 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2014-03-10 | Malfunction | None | Premature Discharge of Battery |
| 2014-03-10 | Injury | None | Migration or Expulsion of Device, Positioning Problem |
| 2014-03-10 | Injury | None | Migration or Expulsion of Device, Unintended Collision, Inappropriate/Inadequate Shock/Stimulation |
| 2014-03-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-03-10 | Injury | None | Failure to Deliver Energy |
| 2014-03-06 | Injury | None | Failure to Deliver Energy, Migration or Expulsion of Device |
| 2014-03-05 | Injury | None | Device Operates Differently Than Expected |
| 2014-03-05 | Injury | None | Intermittent Continuity, Device Operates Differently Than Expected |
| 2014-03-05 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-03-04 | Injury | None | Break, Failure to Deliver Energy, High impedance |
| 2014-03-04 | Malfunction | None | High impedance |
| 2014-03-03 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-03-03 | Injury | None | Device Operates Differently Than Expected |
| 2014-03-01 | Injury | None | Migration or Expulsion of Device |
| 2014-02-24 | Injury | None | Device Or Device Fragments Location Unknown, Compatibility Problem |
| 2014-02-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-02-19 | Injury | None | Use of Device Problem |
| 2014-02-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-02-18 | Injury | None | Intermittent Continuity |
| 2014-02-18 | Injury | None | Break, Migration or Expulsion of Device, Device Operates Differently Than Expected |
| 2014-02-18 | Malfunction | None | Failure to Deliver Energy, Device Or Device Fragments Location Unknown |
| 2014-02-18 | Injury | None | Device Displays Incorrect Message |
| 2014-02-12 | Malfunction | None | High impedance, Unable to Obtain Readings |
| 2014-02-12 | Injury | None | Device Displays Incorrect Message |
| 2014-02-11 | Malfunction | None | Failure to Deliver Energy, Unintended Collision |
| 2014-02-07 | Malfunction | None | Pocket Stimulation, Inappropriate/Inadequate Shock/Stimulation, Low Battery |
| 2014-02-05 | Malfunction | None | High impedance |
| 2014-02-04 | Malfunction | None | Electromagnetic Interference, Failure to Deliver Energy |
| 2014-02-04 | Malfunction | None | Disconnection, Inappropriate/Inadequate Shock/Stimulation |
| 2014-02-03 | Malfunction | None | Low impedance |
| 2014-02-03 | Injury | None | Device Operates Differently Than Expected |
| 2014-02-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-01-31 | Injury | None | Failure to Deliver Energy, Migration or Expulsion of Device, Therapy Delivered to Incorrect Body Area |
| 2014-01-31 | Malfunction | None | Intermittent Continuity, Failure to Deliver Energy, Inappropriate/Inadequate Shock/Stimulation |
| 2014-01-29 | Malfunction | None | Low impedance |
| 2014-01-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-27 | Injury | None | Failure to Deliver Energy |
| 2014-01-24 | Injury | None | Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2014-01-24 | Malfunction | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation |
| 2014-01-24 | Malfunction | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation, Compatibility Problem |
| 2014-01-23 | Injury | None | Break, Unintended Collision |
| 2014-01-16 | Injury | None | Impedance Problem |
| 2014-01-15 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2014-01-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-01-13 | Malfunction | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2014-01-10 | Injury | None | Failure to Deliver Energy |
| 2014-01-08 | Injury | None | Break, Device Or Device Fragments Location Unknown |
| 2014-01-08 | Malfunction | None | Migration or Expulsion of Device, Device Operates Differently Than Expected |
| 2014-01-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-01-03 | Malfunction | None | Break, High impedance, Low Battery, Device Displays Incorrect Message |
| 2014-01-03 | Malfunction | None | High impedance, Low impedance |
| 2014-01-02 | Malfunction | None | Failure to Deliver Energy, High impedance |
| 2014-01-01 | Malfunction | None | Break, Labelling, Instructions for Use or Training Problem, Device Or Device Fragments Location Unknown |
| 2014-01-01 | Injury | None | Intermittent Continuity, Failure to Interrogate, Inappropriate/Inadequate Shock/Stimulation, Malposition of Device, Communication or Transmission Problem |
| 2013-12-30 | Injury | None | Device Operates Differently Than Expected |
| 2013-12-30 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2013-12-28 | Malfunction | None | Energy Output To Patient Tissue Incorrect, Electromagnetic Compatibility Problem |
| 2013-12-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-12-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-12-20 | Injury | None | Device Operates Differently Than Expected |
| 2013-12-20 | Injury | None | Device Operates Differently Than Expected |
| 2013-12-19 | Malfunction | None | Failure to Deliver Energy, Loss of Power, Self-Activation or Keying, Electromagnetic Compatibility Problem |
| 2013-12-19 | Injury | None | Break |
| 2013-12-19 | Malfunction | None | Electromagnetic Interference |
| 2013-12-18 | Injury | None | Migration or Expulsion of Device, Device Operates Differently Than Expected |
| 2013-12-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-12-12 | Injury | None | None |
| 2013-12-12 | Injury | None | Failure to Deliver Energy |
| 2013-12-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-12-11 | Injury | None | Break, Device Or Device Fragments Location Unknown |
| 2013-12-09 | Malfunction | None | None |
| 2013-12-09 | Injury | None | None |
| 2013-12-09 | Injury | None | Operating System Version or Upgrade Problem |
| 2013-12-04 | Injury | None | None |
| 2013-12-03 | Malfunction | None | None |
| 2013-12-03 | Injury | None | None |
| 2013-12-03 | Injury | None | None |
| 2013-12-02 | Injury | None | None |
| 2013-11-30 | Malfunction | None | None |
| 2013-11-29 | Injury | None | None |
| 2013-11-28 | Malfunction | None | Unintended Collision |
| 2013-11-27 | Injury | None | None |
| 2013-11-27 | Injury | None | None |
| 2013-11-26 | Injury | None | None |
| 2013-11-26 | Injury | None | None |
| 2013-11-26 | Malfunction | None | None |
| 2013-11-26 | Injury | None | None |
| 2013-11-25 | Injury | None | None |
| 2013-11-25 | Malfunction | None | None |
| 2013-11-25 | Malfunction | None | None |
| 2013-11-19 | Injury | None | None |
| 2013-11-19 | Injury | None | None |
| 2013-11-18 | Injury | None | None |
| 2013-11-17 | Injury | None | None |
| 2013-11-17 | Injury | None | None |
| 2013-11-15 | Injury | None | None |
| 2013-11-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-11-14 | Injury | None | None |
| 2013-11-13 | Malfunction | None | None |
| 2013-11-12 | Malfunction | None | None |
| 2013-11-09 | Injury | None | None |
| 2013-11-08 | Injury | None | None |
| 2013-11-07 | Malfunction | None | None |
| 2013-11-07 | Injury | None | None |
| 2013-11-07 | Injury | None | None |
| 2013-11-06 | Injury | None | None |
| 2013-11-06 | Injury | None | None |
| 2013-11-06 | Injury | None | None |
| 2013-11-04 | Injury | None | None |
| 2013-11-04 | Injury | None | None |
| 2013-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-10-31 | Injury | None | None |
| 2013-10-31 | Injury | None | None |
| 2013-10-31 | Malfunction | None | None |
| 2013-10-31 | Injury | None | None |
| 2013-10-31 | Malfunction | None | None |
| 2013-10-31 | Injury | None | None |
| 2013-10-30 | Malfunction | None | None |
| 2013-10-30 | Injury | None | None |
| 2013-10-28 | Injury | None | None |
| 2013-10-28 | Malfunction | None | None |
| 2013-10-25 | Injury | None | None |
| 2013-10-24 | Injury | None | None |
| 2013-10-23 | Malfunction | None | None |
| 2013-10-23 | Injury | None | None |
| 2013-10-23 | Injury | None | None |
| 2013-10-22 | Injury | None | Failure to Deliver Energy, High impedance, Unintended Collision |
| 2013-10-22 | Injury | None | High impedance, Device Operates Differently Than Expected |
| 2013-10-21 | Malfunction | None | None |
| 2013-10-21 | Malfunction | None | None |
| 2013-10-21 | Malfunction | None | None |
| 2013-10-17 | Malfunction | None | None |
| 2013-10-16 | Injury | None | None |
| 2013-10-16 | Injury | None | None |
| 2013-10-13 | Injury | None | None |
| 2013-10-11 | Malfunction | None | None |
| 2013-10-10 | Malfunction | None | None |
| 2013-10-10 | Malfunction | None | None |
| 2013-10-10 | Injury | None | None |
| 2013-10-09 | Malfunction | None | None |
| 2013-10-09 | Injury | None | None |
| 2013-10-08 | Injury | None | None |
| 2013-10-08 | Injury | None | None |
| 2013-10-07 | Malfunction | None | None |
| 2013-10-07 | Injury | None | None |
| 2013-10-07 | Injury | None | None |
| 2013-10-07 | Injury | None | None |
| 2013-10-04 | Malfunction | None | None |
| 2013-10-02 | Malfunction | None | None |
| 2013-10-01 | Malfunction | None | None |
| 2013-09-30 | Injury | None | None |
| 2013-09-27 | Malfunction | None | None |
| 2013-09-25 | Malfunction | None | None |
| 2013-09-23 | Injury | None | None |
| 2013-09-23 | Malfunction | None | None |
| 2013-09-21 | Injury | None | None |
| 2013-09-19 | Injury | None | None |
| 2013-09-17 | Injury | None | None |
| 2013-09-16 | Malfunction | None | None |
| 2013-09-16 | Malfunction | None | None |
| 2013-09-16 | Injury | None | None |
| 2013-09-16 | Malfunction | None | None |
| 2013-09-13 | Malfunction | None | None |
| 2013-09-13 | Malfunction | None | None |
| 2013-09-12 | Injury | None | None |
| 2013-09-12 | Injury | None | None |
| 2013-09-12 | Malfunction | None | Failure to Interrogate, Device Displays Incorrect Message, Communication or Transmission Problem, Device Operates Differently Than Expected |
| 2013-09-11 | Injury | None | None |
| 2013-09-10 | Injury | None | None |
| 2013-09-10 | Injury | None | None |
| 2013-09-06 | Injury | None | None |
| 2013-09-05 | Injury | None | None |
| 2013-09-04 | Malfunction | None | None |
| 2013-09-04 | Injury | None | None |
| 2013-09-02 | Malfunction | None | None |
| 2013-08-30 | Injury | None | None |
| 2013-08-28 | Injury | None | Low Battery, Device Displays Incorrect Message |
| 2013-08-27 | Malfunction | None | None |
| 2013-08-27 | Injury | None | None |
| 2013-08-26 | Injury | None | None |
| 2013-08-26 | Injury | None | None |
| 2013-08-23 | Malfunction | None | None |
| 2013-08-23 | Malfunction | None | None |
| 2013-08-23 | Injury | None | None |
| 2013-08-20 | Injury | None | None |
| 2013-08-15 | Malfunction | None | None |
| 2013-08-15 | Malfunction | None | None |
| 2013-08-14 | Injury | None | None |
| 2013-08-14 | Malfunction | None | None |
| 2013-08-13 | Malfunction | None | None |
| 2013-08-13 | Injury | None | Migration or Expulsion of Device, Device Operates Differently Than Expected |
| 2013-08-13 | Malfunction | None | None |
| 2013-08-13 | Malfunction | None | None |
| 2013-08-13 | Malfunction | None | None |
| 2013-08-13 | Malfunction | None | None |
| 2013-08-10 | Malfunction | None | None |
| 2013-08-08 | Injury | None | None |
| 2013-08-08 | Injury | None | None |
| 2013-08-07 | Malfunction | None | None |
| 2013-08-07 | Malfunction | None | None |
| 2013-08-06 | Malfunction | None | None |
| 2013-08-02 | Injury | None | None |
| 2013-07-29 | Malfunction | None | None |
| 2013-07-29 | Injury | None | None |
| 2013-07-28 | Injury | None | Failure to Deliver Energy, Grounding Malfunction, Device Operates Differently Than Expected |
| 2013-07-26 | Malfunction | None | Intermittent Continuity, Failure to Deliver Energy, Energy Output Problem, Device Operates Differently Than Expected, Insufficient Information |
| 2013-07-25 | Malfunction | None | None |
| 2013-07-24 | Injury | None | None |
| 2013-07-24 | Injury | None | None |
| 2013-07-23 | Injury | None | None |
| 2013-07-18 | Injury | None | None |
| 2013-07-18 | Injury | None | None |
| 2013-07-17 | Malfunction | None | None |
| 2013-07-16 | Malfunction | None | None |
| 2013-07-16 | Malfunction | None | None |
| 2013-07-15 | Malfunction | None | None |
| 2013-07-15 | Malfunction | None | None |
| 2013-07-15 | Malfunction | None | None |
| 2013-07-15 | Injury | None | None |
| 2013-07-12 | Malfunction | None | None |
| 2013-07-11 | Injury | None | None |
| 2013-07-11 | Malfunction | None | None |
| 2013-07-11 | Malfunction | None | None |
| 2013-07-09 | Injury | None | None |
| 2013-07-09 | Injury | None | None |
| 2013-07-09 | Injury | None | None |
| 2013-07-08 | Injury | None | None |
| 2013-07-03 | Malfunction | None | None |
| 2013-07-01 | Injury | None | None |
| 2013-06-30 | Injury | None | None |
| 2013-06-28 | Malfunction | None | None |
| 2013-06-28 | Injury | None | None |
| 2013-06-27 | Malfunction | None | None |
| 2013-06-25 | Malfunction | None | None |
| 2013-06-25 | Injury | None | None |
| 2013-06-21 | Malfunction | None | None |
| 2013-06-20 | Injury | None | None |
| 2013-06-20 | Malfunction | None | None |
| 2013-06-18 | Injury | None | None |
| 2013-06-18 | Malfunction | None | None |
| 2013-06-18 | Injury | None | None |
| 2013-06-18 | Malfunction | None | None |
| 2013-06-17 | Injury | None | None |
| 2013-06-17 | Injury | None | None |
| 2013-06-14 | Malfunction | None | None |
| 2013-06-14 | Injury | None | None |
| 2013-06-14 | Injury | None | None |
| 2013-06-14 | Malfunction | None | None |
| 2013-06-13 | Injury | None | None |
| 2013-06-12 | Injury | None | None |
| 2013-06-12 | Injury | None | None |
| 2013-06-11 | Injury | None | None |
| 2013-06-10 | Injury | None | None |
| 2013-06-05 | Injury | None | None |
| 2013-06-03 | Injury | None | None |
| 2013-05-30 | Injury | None | None |
| 2013-05-29 | Malfunction | None | None |
| 2013-05-29 | Injury | None | None |
| 2013-05-28 | Malfunction | None | None |
| 2013-05-28 | Injury | None | Migration or Expulsion of Device, Unintended Collision, Therapy Delivered to Incorrect Body Area, Difficult to Remove, Device Or Device Fragments Location Unknown |
| 2013-05-28 | Injury | None | None |
| 2013-05-28 | Malfunction | None | None |
| 2013-05-24 | Injury | None | None |
| 2013-05-24 | Malfunction | None | None |
| 2013-05-24 | Injury | None | None |
| 2013-05-22 | Injury | None | None |
| 2013-05-21 | Malfunction | None | None |
| 2013-05-16 | Injury | None | None |
| 2013-05-15 | Injury | None | None |
| 2013-05-15 | Injury | None | None |
| 2013-05-14 | Injury | None | None |
| 2013-05-13 | Malfunction | None | None |
| 2013-05-08 | Injury | None | None |
| 2013-05-07 | Injury | None | None |
| 2013-05-06 | Malfunction | None | None |
| 2013-05-06 | Injury | None | None |
| 2013-05-05 | Injury | None | None |
| 2013-05-03 | Malfunction | None | None |
| 2013-05-02 | Malfunction | None | None |
| 2013-04-30 | Injury | None | None |
| 2013-04-29 | Malfunction | None | None |
| 2013-04-29 | Injury | None | None |
| 2013-04-29 | Malfunction | None | None |
| 2013-04-29 | Injury | None | None |
| 2013-04-27 | Injury | None | None |
| 2013-04-26 | Malfunction | None | None |
| 2013-04-25 | Injury | None | None |
| 2013-04-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-04-25 | Injury | None | None |
| 2013-04-25 | Malfunction | None | None |
| 2013-04-25 | Injury | None | None |
| 2013-04-22 | Injury | None | None |
| 2013-04-17 | Injury | None | None |
| 2013-04-16 | Injury | None | None |
| 2013-04-15 | Injury | None | None |
| 2013-04-11 | Injury | None | None |
| 2013-04-10 | Malfunction | None | None |
| 2013-04-08 | Malfunction | None | None |
| 2013-04-08 | Malfunction | None | Coiled, Intermittent Continuity, Failure to Interrogate, Therapy Delivered to Incorrect Body Area, Device Operates Differently Than Expected |
| 2013-04-05 | Malfunction | None | None |
| 2013-04-04 | Malfunction | None | None |
| 2013-04-04 | Injury | None | None |
| 2013-04-04 | Injury | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2013-04-04 | Malfunction | None | Unintended Collision |
| 2013-04-03 | Injury | None | None |
| 2013-04-01 | Injury | None | None |
| 2013-03-31 | Malfunction | None | None |
| 2013-03-29 | Malfunction | None | None |
| 2013-03-29 | Injury | None | None |
| 2013-03-28 | Injury | None | None |
| 2013-03-27 | Injury | None | None |
| 2013-03-27 | Malfunction | None | None |
| 2013-03-27 | Malfunction | None | None |
| 2013-03-26 | Injury | None | None |
| 2013-03-26 | Malfunction | None | None |
| 2013-03-26 | Injury | None | None |
| 2013-03-24 | Malfunction | None | None |
| 2013-03-19 | Malfunction | None | None |
| 2013-03-17 | Malfunction | None | None |
| 2013-03-15 | Injury | None | None |
| 2013-03-15 | Malfunction | None | None |
| 2013-03-14 | Injury | None | None |
| 2013-03-14 | Injury | None | None |
| 2013-03-12 | Malfunction | None | None |
| 2013-03-11 | Malfunction | None | None |
| 2013-03-11 | Injury | None | None |
| 2013-03-08 | Injury | None | None |
| 2013-03-08 | Injury | None | None |
| 2013-03-06 | Injury | None | None |
| 2013-03-05 | Malfunction | None | None |
| 2013-03-05 | Injury | None | None |
| 2013-03-01 | Malfunction | None | None |
| 2013-02-28 | Injury | None | None |
| 2013-02-28 | Malfunction | None | None |
| 2013-02-28 | Malfunction | None | None |
| 2013-02-26 | Injury | None | None |
| 2013-02-25 | Injury | None | None |
| 2013-02-21 | Injury | None | None |
| 2013-02-18 | Malfunction | None | None |
| 2013-02-15 | Injury | None | None |
| 2013-02-14 | Injury | None | None |
| 2013-02-11 | Injury | None | None |
| 2013-02-11 | Injury | None | None |
| 2013-02-06 | Malfunction | None | None |
| 2013-02-06 | Injury | None | None |
| 2013-02-04 | Malfunction | None | None |
| 2013-02-02 | Injury | None | None |
| 2013-02-01 | Malfunction | None | Disconnection, Therapy Delivered to Incorrect Body Area, Inappropriate/Inadequate Shock/Stimulation |
| 2013-01-30 | Malfunction | None | None |
| 2013-01-30 | Injury | None | None |
| 2013-01-30 | Malfunction | None | None |
| 2013-01-30 | Malfunction | None | None |
| 2013-01-29 | Malfunction | None | None |
| 2013-01-25 | Injury | None | None |
| 2013-01-24 | Injury | None | None |
| 2013-01-24 | Malfunction | None | None |
| 2013-01-23 | Malfunction | None | None |
| 2013-01-22 | Injury | None | None |
| 2013-01-18 | Malfunction | None | None |
| 2013-01-17 | Malfunction | None | None |
| 2013-01-16 | Malfunction | None | None |
| 2013-01-16 | Injury | None | None |
| 2013-01-16 | Injury | None | None |
| 2013-01-16 | Injury | None | None |
| 2013-01-15 | Injury | None | None |
| 2013-01-14 | Malfunction | None | None |
| 2013-01-14 | Injury | None | Break, Unintended Collision |
| 2013-01-14 | Malfunction | None | None |
| 2013-01-11 | Malfunction | None | None |
| 2013-01-10 | Injury | None | None |
| 2013-01-10 | Injury | None | None |
| 2013-01-09 | Injury | None | None |
| 2013-01-08 | Injury | None | None |
| 2013-01-08 | Injury | None | None |
| 2013-01-07 | Injury | None | None |
| 2013-01-07 | Injury | None | None |
| 2013-01-03 | Malfunction | None | None |
| 2013-01-03 | Malfunction | None | None |
| 2013-01-02 | Malfunction | None | None |
| 2013-01-02 | Malfunction | None | None |
| 2013-01-01 | Malfunction | None | Migration or Expulsion of Device, Battery Problem |
| 2012-12-31 | Malfunction | None | None |
| 2012-12-31 | Malfunction | None | None |
| 2012-12-27 | Injury | None | None |
| 2012-12-26 | Malfunction | None | Failure to Deliver Energy, Unexpected Therapeutic Results, Low impedance |
| 2012-12-21 | Injury | None | None |
| 2012-12-19 | Injury | None | None |
| 2012-12-17 | Injury | None | None |
| 2012-12-17 | Injury | None | None |
| 2012-12-17 | Injury | None | None |
| 2012-12-17 | Injury | None | None |
| 2012-12-17 | Injury | None | None |
| 2012-12-17 | Injury | None | None |
| 2012-12-14 | Injury | None | None |
| 2012-12-13 | Malfunction | None | None |
| 2012-12-13 | Injury | None | None |
| 2012-12-13 | Injury | None | None |
| 2012-12-12 | Injury | None | None |
| 2012-12-11 | Injury | None | Unexpected Therapeutic Results, Device Operates Differently Than Expected |
| 2012-12-09 | Injury | None | None |
| 2012-12-08 | Malfunction | None | None |
| 2012-12-06 | Malfunction | None | None |
| 2012-12-06 | Injury | None | None |
| 2012-12-03 | Malfunction | None | None |
| 2012-12-01 | Injury | None | Break, Unintended Collision, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2012-11-30 | Malfunction | None | None |
| 2012-11-29 | Injury | None | None |
| 2012-11-27 | Malfunction | None | None |
| 2012-11-27 | Malfunction | None | None |
| 2012-11-26 | Malfunction | None | None |
| 2012-11-20 | Injury | None | None |
| 2012-11-20 | Injury | None | None |
| 2012-11-19 | Injury | None | None |
| 2012-11-14 | Injury | None | None |
| 2012-11-13 | Injury | None | None |
| 2012-11-12 | Injury | None | None |
| 2012-11-12 | Injury | None | None |
| 2012-11-10 | Malfunction | None | None |
| 2012-11-09 | Injury | None | None |
| 2012-11-09 | Injury | None | None |
| 2012-11-09 | Malfunction | None | None |
| 2012-11-08 | Malfunction | None | None |
| 2012-11-07 | Malfunction | None | None |
| 2012-11-07 | Malfunction | None | None |
| 2012-11-06 | Malfunction | None | None |
| 2012-11-05 | Malfunction | None | None |
| 2012-11-05 | Injury | None | None |
| 2012-11-02 | Malfunction | None | None |
| 2012-11-01 | Injury | None | None |
| 2012-11-01 | Injury | None | None |
| 2012-10-31 | Injury | None | None |
| 2012-10-30 | Injury | None | None |
| 2012-10-25 | Malfunction | None | None |
| 2012-10-24 | Death | None | None |
| 2012-10-22 | Malfunction | None | None |
| 2012-10-21 | Malfunction | None | None |
| 2012-10-18 | Injury | None | None |
| 2012-10-18 | Malfunction | None | None |
| 2012-10-16 | Malfunction | None | None |
| 2012-10-12 | Injury | None | None |
| 2012-10-10 | Injury | None | None |
| 2012-10-10 | Malfunction | None | None |
| 2012-10-10 | Injury | None | None |
| 2012-10-08 | Injury | None | None |
| 2012-10-08 | Injury | None | None |
| 2012-10-04 | Injury | None | None |
| 2012-10-04 | Injury | None | None |
| 2012-10-03 | Injury | None | None |
| 2012-10-02 | Injury | None | None |
| 2012-10-02 | Malfunction | None | None |
| 2012-10-01 | Injury | None | None |
| 2012-10-01 | Malfunction | None | None |
| 2012-09-27 | Malfunction | None | None |
| 2012-09-25 | Injury | None | None |
| 2012-09-21 | Injury | None | None |
| 2012-09-21 | Injury | None | None |
| 2012-09-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-09-18 | Injury | None | None |
| 2012-09-18 | Injury | None | None |
| 2012-09-17 | Injury | None | Malposition of Device |
| 2012-09-17 | Injury | None | None |
| 2012-09-17 | Malfunction | None | None |
| 2012-09-15 | Injury | None | None |
| 2012-09-13 | Injury | None | None |
| 2012-09-13 | Injury | None | None |
| 2012-09-12 | Injury | None | None |
| 2012-09-12 | Injury | None | None |
| 2012-09-10 | Injury | None | None |
| 2012-09-08 | Malfunction | None | None |
| 2012-09-06 | Injury | None | None |
| 2012-09-03 | Injury | None | None |
| 2012-09-01 | Injury | None | Break, Therapy Delivered to Incorrect Body Area, Inappropriate/Inadequate Shock/Stimulation |
| 2012-08-30 | Injury | None | None |
| 2012-08-30 | Malfunction | None | None |
| 2012-08-28 | Malfunction | None | None |
| 2012-08-28 | Injury | None | None |
| 2012-08-28 | Malfunction | None | None |
| 2012-08-23 | Malfunction | None | None |
| 2012-08-23 | Malfunction | None | None |
| 2012-08-22 | Injury | None | None |
| 2012-08-21 | Malfunction | None | None |
| 2012-08-17 | Injury | None | None |
| 2012-08-17 | Injury | None | None |
| 2012-08-17 | Malfunction | None | None |
| 2012-08-16 | Malfunction | None | None |
| 2012-08-14 | Injury | None | None |
| 2012-08-14 | Injury | None | None |
| 2012-08-14 | Injury | None | None |
| 2012-08-13 | Injury | None | None |
| 2012-08-07 | Injury | None | None |
| 2012-08-02 | Malfunction | None | None |
| 2012-08-01 | Malfunction | None | None |
| 2012-07-31 | Injury | None | None |
| 2012-07-31 | Malfunction | None | None |
| 2012-07-30 | Injury | None | None |
| 2012-07-26 | Malfunction | None | None |
| 2012-07-25 | Malfunction | None | None |
| 2012-07-23 | Malfunction | None | None |
| 2012-07-23 | Malfunction | None | None |
| 2012-07-23 | Malfunction | None | None |
| 2012-07-20 | Malfunction | None | None |
| 2012-07-18 | Malfunction | None | None |
| 2012-07-18 | Injury | None | None |
| 2012-07-18 | Malfunction | None | None |
| 2012-07-18 | Injury | None | None |
| 2012-07-18 | Injury | None | None |
| 2012-07-17 | Malfunction | None | None |
| 2012-07-17 | Malfunction | None | None |
| 2012-07-17 | Malfunction | None | None |
| 2012-07-17 | Injury | None | None |
| 2012-07-16 | Malfunction | None | None |
| 2012-07-16 | Malfunction | None | None |
| 2012-07-12 | Injury | None | None |
| 2012-07-11 | Malfunction | None | None |
| 2012-07-11 | Injury | None | None |
| 2012-07-08 | Malfunction | None | None |
| 2012-07-05 | Malfunction | None | None |
| 2012-07-05 | Malfunction | None | None |
| 2012-07-03 | Injury | None | None |
| 2012-07-03 | Injury | None | None |
| 2012-07-01 | Injury | None | Device Operates Differently Than Expected |
| 2012-06-29 | Injury | None | None |
| 2012-06-29 | Injury | None | None |
| 2012-06-28 | Malfunction | None | None |
| 2012-06-27 | Injury | None | None |
| 2012-06-27 | Malfunction | None | None |
| 2012-06-26 | Malfunction | None | None |
| 2012-06-25 | Injury | None | None |
| 2012-06-21 | Malfunction | None | None |
| 2012-06-20 | Malfunction | None | None |
| 2012-06-19 | Injury | None | None |
| 2012-06-19 | Injury | None | None |
| 2012-06-18 | Injury | None | None |
| 2012-06-15 | Malfunction | None | None |
| 2012-06-15 | Malfunction | None | None |
| 2012-06-14 | Malfunction | None | None |
| 2012-06-14 | Injury | None | None |
| 2012-06-14 | Injury | None | None |
| 2012-06-14 | Malfunction | None | None |
| 2012-06-11 | Malfunction | None | None |
| 2012-06-11 | Injury | None | None |
| 2012-06-11 | Injury | None | None |
| 2012-06-04 | Malfunction | None | None |
| 2012-06-04 | Malfunction | None | None |
| 2012-06-02 | Injury | None | None |
| 2012-06-02 | Injury | None | None |
| 2012-06-02 | Injury | None | None |
| 2012-06-02 | Injury | None | None |
| 2012-06-02 | Injury | None | None |
| 2012-06-02 | Injury | None | None |
| 2012-06-02 | Injury | None | None |
| 2012-06-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-05-31 | Malfunction | None | None |
| 2012-05-31 | Injury | None | None |
| 2012-05-30 | Malfunction | None | None |
| 2012-05-29 | Injury | None | None |
| 2012-05-25 | Injury | None | None |
| 2012-05-24 | Injury | None | None |
| 2012-05-22 | Malfunction | None | None |
| 2012-05-21 | Malfunction | None | None |
| 2012-05-18 | Injury | None | None |
| 2012-05-18 | Injury | None | None |
| 2012-05-18 | Malfunction | None | None |
| 2012-05-17 | Injury | None | None |
| 2012-05-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-05-15 | Malfunction | None | None |
| 2012-05-15 | Injury | None | None |
| 2012-05-14 | Injury | None | None |
| 2012-05-14 | Injury | None | None |
| 2012-05-10 | Injury | None | None |
| 2012-05-08 | Malfunction | None | None |
| 2012-05-07 | Malfunction | None | None |
| 2012-05-07 | Injury | None | None |
| 2012-05-07 | Injury | None | None |
| 2012-05-04 | Malfunction | None | None |
| 2012-05-02 | Malfunction | None | None |
| 2012-05-01 | Malfunction | None | None |
| 2012-04-30 | Injury | None | None |
| 2012-04-30 | Injury | None | None |
| 2012-04-24 | Injury | None | None |
| 2012-04-23 | Injury | None | None |
| 2012-04-20 | Malfunction | None | None |
| 2012-04-20 | Malfunction | None | None |
| 2012-04-19 | Injury | None | None |
| 2012-04-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-04-17 | Injury | None | None |
| 2012-04-17 | Malfunction | None | None |
| 2012-04-17 | Injury | None | None |
| 2012-04-17 | Malfunction | None | None |
| 2012-04-17 | Malfunction | None | None |
| 2012-04-16 | Injury | None | None |
| 2012-04-12 | Injury | None | None |
| 2012-04-11 | Injury | None | None |
| 2012-04-10 | Injury | None | None |
| 2012-04-09 | Injury | None | None |
| 2012-04-07 | Injury | None | None |
| 2012-04-05 | Malfunction | None | None |
| 2012-04-05 | Malfunction | None | None |
| 2012-04-05 | Malfunction | None | None |
| 2012-04-03 | Malfunction | None | None |
| 2012-04-02 | Malfunction | None | None |
| 2012-03-30 | Malfunction | None | None |
| 2012-03-29 | Injury | None | None |
| 2012-03-29 | Injury | None | None |
| 2012-03-28 | Injury | None | None |
| 2012-03-27 | Malfunction | None | None |
| 2012-03-27 | Injury | None | None |
| 2012-03-27 | Malfunction | None | None |
| 2012-03-26 | Injury | None | None |
| 2012-03-23 | Malfunction | None | None |
| 2012-03-23 | Injury | None | None |
| 2012-03-23 | Injury | None | None |
| 2012-03-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2012-03-21 | Malfunction | None | None |
| 2012-03-21 | Malfunction | None | None |
| 2012-03-20 | Injury | None | None |
| 2012-03-19 | Injury | None | None |
| 2012-03-13 | Injury | None | None |
| 2012-03-09 | Malfunction | None | None |
| 2012-03-08 | Malfunction | None | None |
| 2012-03-06 | Injury | None | None |
| 2012-03-02 | Malfunction | None | None |
| 2012-02-27 | Malfunction | None | None |
| 2012-02-23 | Malfunction | None | None |
| 2012-02-20 | Injury | None | None |
| 2012-02-20 | Injury | None | None |
| 2012-02-14 | Injury | None | None |
| 2012-02-02 | Injury | None | None |
| 2012-02-01 | Injury | None | None |
| 2012-01-30 | Injury | None | None |
| 2012-01-23 | Malfunction | None | None |
| 2012-01-12 | Malfunction | None | Migration or Expulsion of Device |
| 2012-01-05 | Injury | None | None |
| 2012-01-05 | Injury | No Clinical Signs, Symptoms or Conditions | Insufficient Information |
| 2012-01-01 | Injury | None | Electromagnetic Interference, Overheating of Device |
| 2011-12-15 | Injury | None | None |
| 2011-12-14 | Injury | None | None |
| 2011-12-07 | Injury | None | None |
| 2011-12-02 | Malfunction | None | Electromagnetic Interference, Failure to Deliver Energy, Device Operates Differently Than Expected |
| 2011-12-01 | Injury | None | Energy Output To Patient Tissue Incorrect, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected, Electromagnetic Compatibility Problem |
| 2011-11-09 | Injury | None | None |
| 2011-11-08 | Malfunction | None | None |
| 2011-10-25 | Injury | None | None |
| 2011-10-25 | Malfunction | None | None |
| 2011-10-19 | Malfunction | None | None |
| 2011-10-14 | Injury | None | None |
| 2011-09-22 | Injury | None | None |
| 2011-09-12 | Malfunction | None | Break |
| 2011-08-23 | Injury | None | None |
| 2011-08-23 | Injury | None | None |
| 2011-08-22 | Injury | None | None |
| 2011-08-22 | Malfunction | None | None |
| 2011-08-17 | Injury | None | None |
| 2011-07-01 | Malfunction | None | Electromagnetic Interference, Device Operates Differently Than Expected |
| 2011-06-20 | Injury | None | None |
| 2011-06-20 | Injury | None | None |
| 2011-06-02 | Injury | None | None |
| 2011-05-27 | Injury | None | None |
| 2011-05-27 | Injury | None | None |
| 2011-05-01 | Injury | None | None |
| 2011-04-01 | Injury | None | Unintended Collision, Unstable, Material Deformation |
| 2011-03-30 | Injury | None | None |
| 2011-03-22 | Injury | None | Device Operates Differently Than Expected |
| 2011-03-11 | Injury | None | None |
| 2011-03-01 | Injury | None | None |
| 2011-03-01 | Malfunction | None | None |
| 2011-02-23 | Injury | None | None |
| 2011-02-10 | Injury | None | None |
| 2011-02-07 | Malfunction | None | None |
| 2011-02-03 | Injury | None | None |
| 2011-02-01 | Injury | None | Intermittent Continuity, Device Operates Differently Than Expected |
| 2011-01-26 | Injury | None | None |
| 2011-01-14 | Injury | None | None |
| 2011-01-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2011-01-01 | Injury | None | None |
| 2011-01-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2010-12-30 | Injury | None | None |
| 2010-12-15 | Injury | None | None |
| 2010-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2010-12-02 | Injury | None | None |
| 2010-11-24 | Injury | None | None |
| 2010-11-04 | Malfunction | None | None |
| 2010-10-31 | Malfunction | None | None |
| 2010-10-19 | Injury | None | Insufficient Information |
| 2010-10-11 | Injury | None | None |
| 2010-10-01 | Malfunction | None | None |
| 2010-09-09 | Injury | None | None |
| 2010-08-16 | Injury | None | None |
| 2010-08-04 | Injury | None | None |
| 2010-08-01 | Injury | None | None |
| 2010-07-28 | Injury | None | None |
| 2010-07-01 | Malfunction | None | None |
| 2010-07-01 | Malfunction | None | None |
| 2010-06-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2010-06-15 | Injury | None | None |
| 2010-06-01 | Injury | None | None |
| 2010-05-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2010-05-01 | Injury | None | None |
| 2010-04-29 | Malfunction | None | None |
| 2010-03-24 | Injury | None | None |
| 2010-03-01 | Malfunction | None | None |
| 2010-03-01 | Malfunction | None | None |
| 2010-03-01 | Malfunction | None | None |
| 2010-02-22 | Injury | None | None |
| 2010-02-09 | Injury | None | None |
| 2010-01-28 | Injury | None | None |
| 2010-01-20 | Injury | None | None |
| 2010-01-20 | Malfunction | Device Overstimulation of Tissue, Discomfort | Premature Discharge of Battery, Energy Output Problem |
| 2010-01-19 | Malfunction | None | Device Operates Differently Than Expected |
| 2010-01-06 | Injury | None | High impedance, Therapy Delivered to Incorrect Body Area, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2010-01-01 | Malfunction | None | None |
| 2010-01-01 | Injury | No Clinical Signs, Symptoms or Conditions | Insufficient Information |
| 2010-01-01 | Injury | None | Unintended Collision, Device Operates Differently Than Expected |
| 2010-01-01 | Injury | None | Disconnection, Migration or Expulsion of Device, Therapy Delivered to Incorrect Body Area, Device Operates Differently Than Expected |
| 2010-01-01 | Malfunction | None | None |
| 2010-01-01 | Injury | None | Device Or Device Fragments Location Unknown |
| 2009-12-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2009-12-02 | Injury | None | None |
| 2009-12-01 | Malfunction | None | None |
| 2009-11-01 | Injury | None | Break, Inappropriate/Inadequate Shock/Stimulation |
| 2009-11-01 | Malfunction | None | None |
| 2009-10-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2009-09-04 | Injury | None | Device Operates Differently Than Expected |
| 2009-09-03 | Injury | None | None |
| 2009-07-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2009-07-22 | Injury | None | None |
| 2009-07-22 | Injury | None | None |
| 2009-07-03 | Injury | None | Migration or Expulsion of Device, Low Battery |
| 2009-06-30 | Injury | None | Migration or Expulsion of Device |
| 2009-06-15 | Malfunction | None | Device Operates Differently Than Expected |
| 2009-03-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2009-02-27 | Injury | None | None |
| 2009-02-13 | Injury | None | None |
| 2009-01-01 | Injury | None | Break, Adverse Event Without Identified Device or Use Problem |
| 2008-12-29 | Malfunction | None | Shelf Life Exceeded |
| 2008-11-28 | Malfunction | None | Insufficient Information |
| 2008-10-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2008-10-16 | Malfunction | None | Shelf Life Exceeded |
| 2008-09-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2008-07-18 | Injury | None | Insufficient Information |
| 2008-07-08 | Injury | None | None |
| 2008-04-24 | Injury | None | Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2008-04-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2008-04-07 | Injury | None | Difficult to Remove, Device Or Device Fragments Location Unknown, Device Operates Differently Than Expected |
| 2008-03-29 | Malfunction | None | Failure to Deliver Energy |
| 2008-03-26 | Malfunction | None | None |
| 2008-02-01 | Injury | None | Inadequate Instructions for Healthcare Professional, Device Or Device Fragments Location Unknown, Malposition of Device |
| 2008-01-17 | Malfunction | None | Shelf Life Exceeded |
| 2008-01-01 | Injury | None | Electro-Static Discharge |
| 2008-01-01 | Injury | None | Device Operates Differently Than Expected |
| 2008-01-01 | Injury | None | Battery Problem |
| 2008-01-01 | Injury | No Clinical Signs, Symptoms or Conditions | Insufficient Information |
| 2007-12-01 | Injury | None | Battery Problem, Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2007-10-30 | Malfunction | None | Shelf Life Exceeded |
| 2007-09-18 | Injury | None | Battery Problem, Insufficient Information |
| 2007-09-12 | Injury | None | None |
| 2007-09-06 | Injury | None | Unintended Collision, Device Or Device Fragments Location Unknown |
| 2007-07-20 | Malfunction | None | None |
| 2007-04-28 | Injury | None | None |
| 2007-04-01 | Malfunction | None | None |
| 2007-03-28 | Malfunction | None | Failure to Deliver Energy, High impedance, Device Operates Differently Than Expected |
| 2007-01-29 | Injury | None | Intermittent Continuity, Inadequacy of Device Shape and/or Size, Device Operates Differently Than Expected |
| 2007-01-22 | Malfunction | None | None |
| 2007-01-19 | Injury | None | Device Operates Differently Than Expected |
| 2007-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2007-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2006-10-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2006-10-19 | Injury | None | None |
| 2006-09-29 | Injury | None | None |
| 2006-08-11 | Malfunction | None | Electromagnetic Interference, Adverse Event Without Identified Device or Use Problem |
| 2006-08-02 | Malfunction | None | Therapy Delivered to Incorrect Body Area, Malposition of Device, Insufficient Information |
| 2006-05-12 | Injury | None | Device Contamination with Chemical or Other Material, Insufficient Information |
| 2006-05-12 | Injury | None | None |
| 2006-05-03 | Injury | None | Disconnection, Inappropriate/Inadequate Shock/Stimulation |
| 2006-04-28 | Injury | None | Human-Device Interface Problem |
| 2006-04-28 | Malfunction | None | None |
| 2006-03-29 | Injury | None | None |
| 2006-03-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2006-02-20 | Injury | None | None |
| 2006-02-10 | Injury | None | None |
| 2006-01-30 | Injury | None | Device Operates Differently Than Expected |
| 2006-01-01 | Injury | None | Unintended Collision, Insufficient Information |
| 2006-01-01 | Injury | None | Device Operates Differently Than Expected |
| 2006-01-01 | Injury | None | None |
| 2005-12-15 | Injury | None | Device Operates Differently Than Expected |
| 2005-12-06 | Injury | None | None |
| 2005-11-28 | Injury | None | None |
| 2005-11-15 | Malfunction | None | None |
| 2005-08-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2005-08-04 | Injury | None | Device Operates Differently Than Expected, Patient Device Interaction Problem |
| 2005-08-01 | Injury | None | Device Contamination with Chemical or Other Material |
| 2005-07-12 | Injury | None | Migration or Expulsion of Device, Unintended Collision, Inappropriate/Inadequate Shock/Stimulation, Insufficient Information |
| 2005-07-12 | Injury | None | Device Operates Differently Than Expected |
| 2005-06-20 | Malfunction | None | Unintended Collision, Device Operates Differently Than Expected |
| 2005-06-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2005-05-30 | Injury | None | None |
| 2005-04-29 | Malfunction | None | None |
| 2005-04-15 | Injury | None | None |
| 2005-04-15 | Injury | None | None |
| 2005-03-29 | Malfunction | None | Failure to Deliver Energy |
| 2005-03-07 | Injury | None | Device Or Device Fragments Location Unknown, Malposition of Device |
| 2005-02-17 | Injury | None | None |
| 2005-01-27 | Injury | None | None |
| 2005-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2005-01-01 | Injury | None | Break, Malposition of Device, Device Operates Differently Than Expected |
| 2004-11-01 | Injury | None | None |
| 2004-09-14 | Injury | None | None |
| 2004-07-22 | Injury | None | None |
| 2004-07-13 | Malfunction | None | Unintended Collision, Battery Problem, Insufficient Information |
| 2004-05-21 | Injury | None | Low Battery, Device Operates Differently Than Expected |
| 2004-01-21 | Injury | None | Intermittent Continuity, Therapy Delivered to Incorrect Body Area, Unexpected Therapeutic Results, Device Operates Differently Than Expected |
| 2004-01-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2004-01-08 | Injury | None | None |
| 2003-11-17 | Malfunction | None | Shelf Life Exceeded |
| 2003-09-14 | Injury | None | Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2003-08-19 | Malfunction | None | Electromagnetic Interference, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2003-06-06 | Injury | None | Device Operates Differently Than Expected |
| 2003-05-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2003-04-18 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2003-03-10 | Malfunction | None | Migration or Expulsion of Device |
| 2003-02-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2003-01-01 | Injury | None | Device Operates Differently Than Expected |
| 2003-01-01 | Injury | None | Inappropriate/Inadequate Shock/Stimulation, Device Or Device Fragments Location Unknown |
| 2003-01-01 | Injury | None | Unintended Collision |
| 2002-11-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2002-11-06 | Injury | None | Migration or Expulsion of Device, Therapy Delivered to Incorrect Body Area, Malposition of Device, Adverse Event Without Identified Device or Use Problem |
| 2002-09-27 | Injury | None | Device Operates Differently Than Expected |
| 2002-05-01 | Injury | None | Device Operates Differently Than Expected |
| 2002-04-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2002-03-01 | Injury | None | None |
| 2002-02-18 | Injury | None | Battery Problem, Environmental Compatibility Problem |
| 2002-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2000-10-11 | Injury | None | Malposition of Device, Device Operates Differently Than Expected |
| 2000-07-25 | Injury | None | Device Operates Differently Than Expected |