PULSE GENERATOR, PERMANENT, IMPLANTABLE
This device is manufactured by MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC SA, MEDTRONIC SA (SMO), MEDTRONIC SINGAPORE OPERATIONS, RICE CREEK MFG.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-06-18 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-05-23 | Malfunction | Failure of Implant | None |
| 2024-03-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Appropriate Term/Code Not Available |
| 2023-12-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-18 | Malfunction | Appropriate Term / Code Not Available | None |
| 2023-11-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-11-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2023-11-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Mechanical Problem |
| 2023-10-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Mechanical Problem |
| 2023-10-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pacing Problem |
| 2023-10-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-09-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2023-09-08 | Injury | Presyncope | Failure to Capture |
| 2023-08-07 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-07-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Appropriate Term/Code Not Available |
| 2023-06-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Mechanical Problem |
| 2023-04-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Mechanical Problem |
| 2023-02-26 | Malfunction | Chest Pain | Pacing Problem |
| 2023-02-26 | Malfunction | Bradycardia | Premature Discharge of Battery, Pacing Problem |
| 2023-01-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Mechanical Problem |
| 2022-11-04 | Malfunction | None | Appropriate Term/Code Not Available |
| 2022-10-24 | Malfunction | None | Pacing Problem |
| 2022-10-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Reset Problem |
| 2022-10-12 | Malfunction | None | Unable to Obtain Readings |
| 2022-09-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2022-07-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Device Sensing Problem |
| 2022-06-24 | Malfunction | None | Pacing Problem, Output Problem |
| 2022-06-09 | Malfunction | None | Mechanical Problem, Pacing Problem |
| 2022-04-12 | Malfunction | None | Premature Discharge of Battery |
| 2022-03-29 | Malfunction | None | Battery Problem |
| 2021-12-01 | Malfunction | None | Premature Discharge of Battery |
| 2020-08-19 | Malfunction | Pain | Insufficient Information |
| 2019-09-17 | Injury | None | Premature Discharge of Battery |
| 2019-09-16 | Injury | None | Pacing Problem |
| 2019-09-04 | Malfunction | None | Mechanical Problem, Over-Sensing, Pacing Problem |
| 2019-08-29 | Malfunction | None | Premature Discharge of Battery |
| 2019-08-22 | Injury | None | Reset Problem |
| 2019-08-19 | Malfunction | None | Pacing Problem |
| 2019-08-16 | Malfunction | None | Mechanical Problem |
| 2019-08-14 | Injury | None | Pacing Problem |
| 2019-08-06 | Malfunction | None | Communication or Transmission Problem |
| 2019-07-25 | Malfunction | None | Signal Artifact/Noise, Electromagnetic Interference |
| 2019-07-25 | Malfunction | None | Premature Discharge of Battery |
| 2019-07-22 | Injury | None | Pacing Problem |
| 2019-07-22 | Injury | None | Pacing Problem |
| 2019-07-17 | Malfunction | None | Unable to Obtain Readings |
| 2019-07-15 | Malfunction | None | Mechanical Problem |
| 2019-07-15 | Malfunction | None | Device Sensing Problem |
| 2019-07-15 | Malfunction | None | Data Problem |
| 2019-06-28 | Injury | None | Appropriate Term/Code Not Available |
| 2019-06-27 | Malfunction | None | Pacing Problem |
| 2019-06-27 | Malfunction | None | Over-Sensing, Pacing Problem |
| 2019-06-26 | Malfunction | None | Pacing Problem |
| 2019-06-24 | Malfunction | None | Mechanical Problem, Device Damaged by Another Device |
| 2019-06-18 | Malfunction | None | Pacing Problem |
| 2019-06-13 | Malfunction | None | Pacing Problem |
| 2019-06-12 | Malfunction | None | Failure to Interrogate |
| 2019-06-01 | Malfunction | None | Pacing Problem |
| 2019-05-23 | Malfunction | None | Under-Sensing |
| 2019-05-22 | Malfunction | None | Pacing Problem |
| 2019-05-22 | Malfunction | None | Pacing Problem |
| 2019-05-17 | Malfunction | None | Mechanical Problem |
| 2019-05-07 | Injury | None | Pacing Problem |
| 2019-05-03 | Malfunction | None | Pacing Problem |
| 2019-05-01 | Injury | None | Premature Discharge of Battery |
| 2019-04-22 | Malfunction | None | Mechanical Problem |
| 2019-04-20 | Injury | None | Pacing Problem |
| 2019-04-18 | Malfunction | None | Mechanical Problem |
| 2019-04-10 | Malfunction | None | Premature Discharge of Battery |
| 2019-04-09 | Malfunction | None | Pacing Problem |
| 2019-04-01 | Malfunction | None | Mechanical Problem |
| 2019-03-25 | Injury | None | Premature Discharge of Battery |
| 2019-03-25 | Malfunction | None | Premature Discharge of Battery |
| 2019-03-22 | Malfunction | None | Appropriate Term/Code Not Available |
| 2019-03-20 | Malfunction | None | Failure to Interrogate, Incorrect, Inadequate or Imprecise Result or Readings |
| 2019-03-16 | Malfunction | None | Mechanical Problem |
| 2019-03-13 | Malfunction | None | Pacing Problem |
| 2019-03-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-12 | Malfunction | None | Premature Discharge of Battery |
| 2019-03-05 | Malfunction | None | Electromagnetic Interference, Over-Sensing |
| 2019-03-01 | Injury | None | Failure to Capture |
| 2019-02-18 | Malfunction | None | Over-Sensing |
| 2019-02-17 | Injury | None | Premature Discharge of Battery |
| 2019-02-12 | Malfunction | None | Over-Sensing |
| 2019-02-07 | Malfunction | None | Pacing Problem |
| 2019-02-07 | Malfunction | None | Pacing Problem |
| 2019-02-06 | Malfunction | None | Pacing Problem, Device Sensing Problem |
| 2019-01-31 | Malfunction | None | Mechanical Problem |
| 2019-01-30 | Malfunction | None | Mechanical Problem |
| 2019-01-30 | Malfunction | None | Mechanical Problem |
| 2019-01-24 | Malfunction | None | Premature Discharge of Battery |
| 2019-01-24 | Malfunction | None | Pacing Problem, High Capture Threshold |
| 2019-01-23 | Malfunction | None | Pacing Problem |
| 2019-01-22 | Malfunction | None | Mechanical Problem |
| 2019-01-16 | Malfunction | None | Misconnection |
| 2019-01-11 | Malfunction | None | Pacing Problem |
| 2019-01-04 | Malfunction | None | Failure to Capture |
| 2018-12-30 | Malfunction | None | Appropriate Term/Code Not Available |
| 2018-12-26 | Malfunction | None | Mechanical Problem |
| 2018-12-24 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2018-12-19 | Malfunction | None | Pacing Problem |
| 2018-12-19 | Malfunction | None | Mechanical Problem |
| 2018-12-17 | Malfunction | None | Failure to Capture, Pacing Problem |
| 2018-12-13 | Malfunction | None | Mechanical Problem |
| 2018-12-11 | Malfunction | None | High impedance, Mechanical Problem, High Capture Threshold |
| 2018-12-11 | Malfunction | None | Electrical /Electronic Property Problem |
| 2018-12-08 | Malfunction | None | Pacing Problem |
| 2018-12-06 | Malfunction | None | Premature Discharge of Battery |
| 2018-12-05 | Malfunction | None | Misconnection |
| 2018-12-04 | Injury | None | Appropriate Term/Code Not Available |
| 2018-12-04 | Injury | None | Premature Discharge of Battery |
| 2018-11-29 | Malfunction | None | Reset Problem |
| 2018-11-28 | Malfunction | None | Pacing Problem |
| 2018-11-28 | Malfunction | None | Defective Device |
| 2018-11-27 | Malfunction | None | Premature Discharge of Battery |
| 2018-11-22 | Malfunction | None | Unable to Obtain Readings, Output Problem |
| 2018-11-20 | Malfunction | None | Mechanical Problem |
| 2018-11-19 | Malfunction | None | Mechanical Problem |
| 2018-11-19 | Malfunction | None | Premature Discharge of Battery |
| 2018-11-16 | Malfunction | None | Incorrect Measurement |
| 2018-11-14 | Malfunction | None | Device-Device Incompatibility |
| 2018-11-08 | Malfunction | None | Mechanical Problem |
| 2018-11-08 | Injury | None | Premature Discharge of Battery |
| 2018-11-06 | Injury | None | Device Contamination with Body Fluid |
| 2018-11-02 | Malfunction | None | Device Sensing Problem |
| 2018-11-01 | Malfunction | None | Pacing Problem |
| 2018-10-19 | Malfunction | None | Mechanical Problem, Device Sensing Problem |
| 2018-10-16 | Malfunction | None | Pacing Problem |
| 2018-10-08 | Malfunction | None | Pacing Problem |
| 2018-09-30 | Injury | None | Device Sensing Problem |
| 2018-09-27 | Malfunction | None | Mechanical Problem |
| 2018-09-26 | Malfunction | None | Electrical /Electronic Property Problem, Device Sensing Problem |
| 2018-09-19 | Injury | None | Signal Artifact/Noise, Electromagnetic Interference, Mechanical Problem, Over-Sensing, Device-Device Incompatibility |
| 2018-09-17 | Malfunction | None | Pacing Problem |
| 2018-09-13 | Malfunction | None | Premature Discharge of Battery, Appropriate Term/Code Not Available |
| 2018-09-06 | Injury | None | Intermittent Capture, Failure to Capture |
| 2018-09-05 | Malfunction | None | Over-Sensing |
| 2018-09-03 | Malfunction | None | Mechanical Problem |
| 2018-09-03 | Injury | None | Appropriate Term/Code Not Available |
| 2018-09-01 | Malfunction | None | Device-Device Incompatibility |
| 2018-08-20 | Malfunction | None | Over-Sensing, Device Sensing Problem |
| 2018-08-17 | Malfunction | None | Premature Discharge of Battery |
| 2018-08-17 | Malfunction | None | Mechanical Problem |
| 2018-07-30 | Injury | None | Pocket Stimulation |
| 2018-07-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-26 | Malfunction | None | Device Sensing Problem |
| 2018-07-23 | Malfunction | None | Pacing Problem |
| 2018-07-13 | Injury | None | Device Dislodged or Dislocated, Insufficient Information |
| 2018-07-10 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2018-07-09 | Malfunction | None | Pacing Problem, Appropriate Term/Code Not Available |
| 2018-07-09 | Malfunction | None | Device Sensing Problem |
| 2018-07-06 | Malfunction | None | Over-Sensing, Under-Sensing, Decreased Sensitivity, Noise, Audible |
| 2018-07-04 | Malfunction | None | Loose or Intermittent Connection, Mechanical Problem |
| 2018-07-02 | Malfunction | None | Mechanical Problem, Difficult to Remove, Improper or Incorrect Procedure or Method |
| 2018-06-29 | Malfunction | None | Failure to Capture, Malposition of Device, No Pacing |
| 2018-06-28 | Malfunction | None | Mechanical Problem, Detachment of Device or Device Component |
| 2018-06-22 | Malfunction | None | Failure to Capture, Over-Sensing, Device Sensing Problem |
| 2018-06-21 | Malfunction | None | Premature Discharge of Battery |
| 2018-06-07 | Injury | None | Failure to Capture, Over-Sensing |
| 2018-06-07 | Malfunction | None | Premature Discharge of Battery |
| 2018-06-01 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2018-06-01 | Injury | None | Mechanical Problem |
| 2018-06-01 | Malfunction | None | Premature Discharge of Battery |
| 2018-05-31 | Malfunction | None | Device Sensing Problem |
| 2018-05-29 | Malfunction | None | Failure to Capture, Over-Sensing, Pacing Problem |
| 2018-05-21 | Malfunction | None | Mechanical Problem, Material Integrity Problem |
| 2018-05-21 | Malfunction | None | Mechanical Problem, Misconnection |
| 2018-05-17 | Injury | None | High impedance, Failure to Interrogate, Loose or Intermittent Connection, Mechanical Problem |
| 2018-05-15 | Malfunction | None | Misconnection, Pacing Problem |
| 2018-05-15 | Malfunction | None | Misconnection, Pacing Problem |
| 2018-05-11 | Malfunction | None | Migration or Expulsion of Device |
| 2018-05-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-05-11 | Injury | None | Battery Problem, Capturing Problem |
| 2018-05-04 | Injury | None | Device Sensing Problem |
| 2018-04-30 | Malfunction | None | Mechanical Problem |
| 2018-04-23 | Injury | None | Pacing Problem |
| 2018-04-20 | Malfunction | None | Pacing Problem |
| 2018-04-19 | Malfunction | None | Pacing Problem |
| 2018-04-19 | Injury | None | Use of Device Problem |
| 2018-04-18 | Malfunction | None | Battery Problem |
| 2018-04-18 | Malfunction | None | Pacing Problem |
| 2018-04-16 | Malfunction | None | Capturing Problem, Device Operates Differently Than Expected |
| 2018-04-12 | Malfunction | None | Premature Discharge of Battery |
| 2018-04-10 | Malfunction | None | Intermittent Capture |
| 2018-04-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-04 | Injury | None | Pacing Problem |
| 2018-04-03 | Malfunction | None | Unable to Obtain Readings |
| 2018-03-30 | Malfunction | None | Mechanical Problem |
| 2018-03-28 | Malfunction | None | Mechanical Problem |
| 2018-03-28 | Malfunction | None | High impedance, Device Sensing Problem |
| 2018-03-26 | Malfunction | None | Pacing Problem |
| 2018-03-26 | Malfunction | None | Mechanical Problem |
| 2018-03-20 | Malfunction | None | Failure to Capture, Pacing Problem |
| 2018-03-19 | Malfunction | None | Failure to Capture, Pacing Problem |
| 2018-03-16 | Malfunction | None | Mechanical Problem |
| 2018-03-15 | Malfunction | None | Mechanical Problem |
| 2018-03-15 | Malfunction | None | Mechanical Problem |
| 2018-03-12 | Injury | None | Failure to Interrogate |
| 2018-03-12 | Malfunction | None | Pacing Problem |
| 2018-03-05 | Malfunction | None | Pacing Problem |
| 2018-03-04 | Malfunction | None | Signal Artifact/Noise |
| 2018-03-02 | Malfunction | None | Pacing Problem |
| 2018-03-01 | Malfunction | None | Mechanical Problem |
| 2018-03-01 | Malfunction | None | Over-Sensing, Pacing Problem, Under-Sensing |
| 2018-03-01 | Malfunction | None | Mechanical Problem |
| 2018-02-18 | Malfunction | None | Premature Discharge of Battery |
| 2018-02-13 | Malfunction | None | Mechanical Problem |
| 2018-02-13 | Malfunction | None | Premature Discharge of Battery |
| 2018-02-09 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2018-02-08 | Malfunction | None | Over-Sensing |
| 2018-02-08 | Malfunction | None | Over-Sensing |
| 2018-02-08 | Malfunction | None | Battery Problem |
| 2018-02-05 | Malfunction | None | Mechanical Problem |
| 2018-01-24 | Injury | None | Migration or Expulsion of Device |
| 2018-01-17 | Malfunction | None | Reset Problem |
| 2018-01-13 | Malfunction | None | Premature Discharge of Battery |
| 2018-01-12 | Malfunction | None | Pacing Problem, Device Operates Differently Than Expected |
| 2018-01-09 | Malfunction | None | Premature Discharge of Battery |
| 2017-12-27 | Malfunction | None | Mechanical Problem |
| 2017-12-23 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-21 | Malfunction | None | Mechanical Problem |
| 2017-12-18 | Malfunction | None | Mechanical Problem |
| 2017-12-13 | Malfunction | None | Premature Discharge of Battery |
| 2017-12-13 | Injury | None | Pacing Problem, High Capture Threshold |
| 2017-12-13 | Malfunction | None | Pacing Problem, Under-Sensing |
| 2017-12-05 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-12-04 | Malfunction | None | Premature Discharge of Battery |
| 2017-12-01 | Malfunction | None | Pacing Problem |
| 2017-12-01 | Malfunction | None | Mechanical Problem |
| 2017-11-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-29 | Malfunction | None | Pacing Problem |
| 2017-11-20 | Malfunction | None | Mechanical Problem, Misconnection |
| 2017-11-19 | Malfunction | None | Pacing Problem |
| 2017-11-15 | Malfunction | None | Premature Discharge of Battery |
| 2017-11-10 | Malfunction | None | Mechanical Problem |
| 2017-11-09 | Injury | None | Premature Discharge of Battery |
| 2017-11-02 | Malfunction | None | Device Expiration Issue |
| 2017-11-01 | Malfunction | None | Migration or Expulsion of Device |
| 2017-10-26 | Malfunction | None | Pacing Problem |
| 2017-10-25 | Injury | None | Premature Discharge of Battery, Pacing Problem |
| 2017-10-25 | Malfunction | None | Battery Problem |
| 2017-10-20 | Malfunction | None | Loose or Intermittent Connection, Pacing Problem |
| 2017-10-17 | Malfunction | None | Mechanical Problem |
| 2017-10-17 | Malfunction | None | Premature Discharge of Battery |
| 2017-09-29 | Malfunction | None | Pacing Problem |
| 2017-09-22 | Malfunction | None | Mechanical Problem |
| 2017-09-19 | Malfunction | None | Capturing Problem |
| 2017-09-15 | Malfunction | None | Mechanical Problem |
| 2017-09-12 | Malfunction | None | Battery Problem |
| 2017-09-05 | Malfunction | None | Pacing Problem |
| 2017-09-04 | Injury | None | Mechanical Problem |
| 2017-09-01 | Malfunction | None | Over-Sensing |
| 2017-09-01 | Malfunction | None | Mechanical Problem |
| 2017-08-31 | Malfunction | None | Mechanical Problem |
| 2017-08-30 | Injury | Unspecified Infection | Insufficient Information |
| 2017-08-29 | Malfunction | None | Output Problem |
| 2017-08-22 | Injury | None | Mechanical Problem, Pacing Problem, Capturing Problem |
| 2017-08-22 | Malfunction | None | Over-Sensing |
| 2017-08-22 | Malfunction | None | Capturing Problem |
| 2017-08-21 | Malfunction | None | Mechanical Problem, Misconnection |
| 2017-08-21 | Malfunction | None | Device Sensing Problem |
| 2017-08-21 | Malfunction | None | Unable to Obtain Readings |
| 2017-08-17 | Injury | None | Migration or Expulsion of Device |
| 2017-08-15 | Malfunction | None | Mechanical Problem, Device Damaged by Another Device |
| 2017-08-14 | Malfunction | None | Failure to Interrogate, Pacing Problem |
| 2017-08-06 | Malfunction | None | Premature Discharge of Battery |
| 2017-08-01 | Malfunction | None | Appropriate Term/Code Not Available |
| 2017-08-01 | Malfunction | None | Premature Discharge of Battery |
| 2017-07-31 | Injury | None | Premature Discharge of Battery |
| 2017-07-30 | Malfunction | None | Pacing Problem |
| 2017-07-28 | Malfunction | None | Battery Problem |
| 2017-07-25 | Malfunction | None | Missing Test Results |
| 2017-07-21 | Malfunction | None | Incorrect Measurement |
| 2017-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-17 | Injury | None | Pacing Problem, No Pacing |
| 2017-07-17 | Injury | None | Premature Discharge of Battery |
| 2017-07-07 | Injury | None | Mechanical Problem |
| 2017-07-01 | Injury | None | Premature Discharge of Battery |
| 2017-06-26 | Malfunction | None | Unable to Obtain Readings |
| 2017-06-20 | Injury | None | Inappropriate or Unexpected Reset |
| 2017-06-10 | Malfunction | None | Invalid Sensing |
| 2017-06-09 | Malfunction | None | Mechanical Problem |
| 2017-06-08 | Malfunction | None | Misconnection, Pacing Problem |
| 2017-06-05 | Malfunction | None | Mechanical Problem, Misconnection |
| 2017-06-01 | Injury | None | Appropriate Term/Code Not Available |
| 2017-06-01 | Malfunction | None | Pacing Problem |
| 2017-06-01 | Malfunction | None | Over-Sensing, Pacing Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-05-30 | Malfunction | None | Misconnection |
| 2017-05-25 | Malfunction | None | Premature Discharge of Battery |
| 2017-05-18 | Malfunction | None | High impedance, Mechanical Problem, High Capture Threshold |
| 2017-05-18 | Malfunction | None | Premature Discharge of Battery |
| 2017-05-17 | Malfunction | None | Premature Discharge of Battery |
| 2017-05-17 | Malfunction | None | Battery Problem |
| 2017-05-12 | Malfunction | None | Mechanical Problem |
| 2017-05-05 | Malfunction | None | Mechanical Problem, Over-Sensing, Under-Sensing, Capturing Problem, Device Sensing Problem |
| 2017-05-04 | Malfunction | None | Under-Sensing |
| 2017-05-01 | Malfunction | None | Premature Discharge of Battery |
| 2017-04-26 | Malfunction | None | Pacing Problem |
| 2017-04-20 | Malfunction | None | Pacing Problem, Device Sensing Problem |
| 2017-04-13 | Malfunction | None | Premature Discharge of Battery |
| 2017-04-12 | Malfunction | None | Premature Discharge of Battery |
| 2017-04-10 | Malfunction | None | Mechanical Problem, Misconnection |
| 2017-04-05 | Injury | None | Mechanical Problem |
| 2017-03-30 | Malfunction | None | Over-Sensing |
| 2017-03-24 | Malfunction | None | Output above Specifications |
| 2017-03-21 | Malfunction | None | Over-Sensing |
| 2017-03-21 | Injury | None | Pacing Problem |
| 2017-03-20 | Injury | None | Positioning Problem |
| 2017-03-14 | Malfunction | None | Appropriate Term/Code Not Available |
| 2017-03-06 | Injury | None | Misconnection, Pacing Problem |
| 2017-02-22 | Malfunction | None | Unable to Obtain Readings |
| 2017-02-18 | Malfunction | None | Premature Discharge of Battery |
| 2017-02-15 | Malfunction | None | Incorrect Measurement, Over-Sensing |
| 2017-02-13 | Injury | None | Mechanical Problem, Unable to Obtain Readings |
| 2017-02-11 | Malfunction | None | Pacing Problem, Device Sensing Problem |
| 2017-02-06 | Malfunction | None | Over-Sensing |
| 2017-02-02 | Malfunction | None | Signal Artifact/Noise, Electromagnetic Interference, Over-Sensing |
| 2017-02-02 | Malfunction | None | Misconnection |
| 2017-02-01 | Malfunction | None | Mechanical Problem |
| 2017-01-30 | Malfunction | None | Premature Discharge of Battery |
| 2017-01-26 | Malfunction | None | Pacing Problem |
| 2017-01-25 | Malfunction | None | High impedance, Device Operates Differently Than Expected, Impedance Problem, Output Problem |
| 2017-01-23 | Malfunction | None | Pacing Problem |
| 2017-01-17 | Injury | None | Pacing Problem |
| 2017-01-16 | Malfunction | None | Pacing Problem |
| 2017-01-12 | Malfunction | None | Premature Discharge of Battery |
| 2017-01-12 | Malfunction | Insufficient Information | Failure to Capture |
| 2017-01-11 | Malfunction | None | Premature Discharge of Battery |
| 2017-01-09 | Malfunction | None | Failure to Interrogate |
| 2017-01-05 | Malfunction | None | Pacing Problem, Device Operates Differently Than Expected |
| 2017-01-04 | Malfunction | None | Mechanical Problem |
| 2017-01-01 | Malfunction | None | Device Operates Differently Than Expected, Device Sensing Problem |
| 2017-01-01 | Injury | None | Failure to Capture, Pacing Problem, Under-Sensing |
| 2016-12-30 | Malfunction | None | Capturing Problem |
| 2016-12-30 | Malfunction | None | Capturing Problem |
| 2016-12-22 | Malfunction | None | Premature Discharge of Battery |
| 2016-12-20 | Malfunction | None | Mechanical Problem |
| 2016-12-20 | Malfunction | None | Mechanical Problem |
| 2016-12-19 | Malfunction | None | Pacing Problem |
| 2016-12-14 | Malfunction | None | Incorrect Measurement, Unable to Obtain Readings, Inappropriate or Unexpected Reset |
| 2016-12-14 | Malfunction | None | Premature Discharge of Battery |
| 2016-12-12 | Malfunction | None | Mechanical Problem |
| 2016-12-06 | Malfunction | None | Unable to Obtain Readings |
| 2016-12-06 | Malfunction | None | Premature Discharge of Battery |
| 2016-12-03 | Malfunction | None | Premature Discharge of Battery |
| 2016-12-01 | Malfunction | None | Migration or Expulsion of Device |
| 2016-11-29 | Malfunction | None | Premature Discharge of Battery |
| 2016-11-28 | Malfunction | None | Premature Discharge of Battery |
| 2016-11-25 | Malfunction | None | Over-Sensing, Pacing Problem |
| 2016-11-24 | Malfunction | None | Pacing Problem |
| 2016-11-18 | Malfunction | None | Mechanical Problem |
| 2016-11-16 | Malfunction | None | Premature Discharge of Battery |
| 2016-11-16 | Malfunction | None | Use of Device Problem |
| 2016-11-07 | Malfunction | None | Mechanical Problem |
| 2016-11-02 | Malfunction | None | Pacing Problem |
| 2016-11-01 | Injury | None | Impedance Problem |
| 2016-10-28 | Malfunction | None | Under-Sensing |
| 2016-10-25 | Injury | None | Incorrect Measurement, Unable to Obtain Readings, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2016-10-24 | Malfunction | None | Unable to Obtain Readings, Output Problem |
| 2016-10-21 | Malfunction | None | Mechanical Problem |
| 2016-10-16 | Malfunction | None | Premature Discharge of Battery |
| 2016-10-11 | Malfunction | None | Mechanical Problem, Delivered as Unsterile Product, Manufacturing, Packaging or Shipping Problem |
| 2016-10-05 | Malfunction | None | Mechanical Problem, Decreased Sensitivity |
| 2016-10-03 | Malfunction | None | Incorrect Measurement |
| 2016-10-03 | Injury | None | Failure to Capture |
| 2016-09-30 | Malfunction | None | Mechanical Problem, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2016-09-29 | Malfunction | None | Failure to Interrogate, Pacing Problem |
| 2016-09-23 | Malfunction | None | Mechanical Problem, Pacing Problem |
| 2016-09-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-16 | Malfunction | None | Over-Sensing, Communication or Transmission Problem |
| 2016-09-16 | Malfunction | None | Mechanical Problem, Pacing Problem, Device Sensing Problem |
| 2016-09-15 | Injury | None | Premature Discharge of Battery |
| 2016-09-14 | Malfunction | None | Unable to Obtain Readings |
| 2016-09-14 | Malfunction | None | Over-Sensing |
| 2016-09-13 | Injury | None | Premature Discharge of Battery |
| 2016-09-09 | Malfunction | None | Protective Measures Problem |
| 2016-08-24 | Injury | None | Misconnection, Pacing Problem |
| 2016-08-18 | Injury | None | Migration or Expulsion of Device, Positioning Problem |
| 2016-08-04 | Malfunction | None | Mechanical Problem, Pacing Problem |
| 2016-07-30 | Malfunction | None | Under-Sensing, Invalid Sensing |
| 2016-07-29 | Malfunction | None | Use of Device Problem |
| 2016-07-29 | Malfunction | None | Unable to Obtain Readings |
| 2016-07-29 | Injury | None | Appropriate Term/Code Not Available |
| 2016-07-27 | Malfunction | None | Unable to Obtain Readings |
| 2016-07-25 | Malfunction | None | Migration or Expulsion of Device |
| 2016-07-20 | Malfunction | None | Premature Discharge of Battery |
| 2016-07-19 | Malfunction | None | Incorrect Measurement, Unable to Obtain Readings |
| 2016-07-19 | Malfunction | None | Premature Discharge of Battery |
| 2016-07-13 | Malfunction | None | Premature Discharge of Battery |
| 2016-07-08 | Malfunction | None | Failure to Interrogate, Pacing Problem |
| 2016-07-08 | Injury | None | Unable to Obtain Readings, Reset Problem |
| 2016-06-28 | Injury | None | Mechanical Problem |
| 2016-06-21 | Malfunction | None | Invalid Sensing, Device Operates Differently Than Expected |
| 2016-06-17 | Malfunction | None | Misconnection |
| 2016-06-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Migration or Expulsion of Device |
| 2016-06-08 | Malfunction | None | Mechanical Problem |
| 2016-06-07 | Injury | None | Pacing Problem |
| 2016-06-07 | Malfunction | None | Premature Discharge of Battery |
| 2016-06-05 | Injury | None | Over-Sensing, Pacing Problem |
| 2016-06-01 | Malfunction | None | Mechanical Problem |
| 2016-05-31 | Malfunction | None | Migration or Expulsion of Device |
| 2016-05-28 | Injury | None | Premature Discharge of Battery |
| 2016-05-27 | Malfunction | None | Communication or Transmission Problem |
| 2016-05-27 | Malfunction | None | Premature Discharge of Battery |
| 2016-05-14 | Malfunction | None | Mechanical Problem |
| 2016-05-12 | Injury | None | Premature Discharge of Battery, Failure to Interrogate, Pacing Problem |
| 2016-05-04 | Injury | None | Pacing Problem |
| 2016-03-18 | Malfunction | None | Device Sensing Problem |
| 2016-01-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-05-12 | Death | None | Capturing Problem |
| 2015-05-07 | Malfunction | None | Electrical /Electronic Property Problem, Invalid Sensing |
| 2015-02-01 | Injury | None | Premature Discharge of Battery, Incorrect Measurement, Unable to Obtain Readings |
| 2015-02-01 | Injury | None | Pacing Problem |
| 2014-07-28 | Malfunction | None | High impedance, Misconnection, Impedance Problem |
| 2014-06-23 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2014-06-19 | Malfunction | None | Mechanical Problem |
| 2014-06-16 | Injury | None | Migration or Expulsion of Device |
| 2014-06-09 | Injury | None | Under-Sensing |
| 2014-06-08 | Malfunction | None | Pacing Problem |
| 2014-06-06 | Injury | None | Premature Discharge of Battery |
| 2014-05-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-05-24 | Malfunction | None | Pacing Problem, Incorrect, Inadequate or Imprecise Result or Readings |
| 2014-05-20 | Injury | None | Pacing Problem |
| 2014-05-19 | Injury | None | Pacing Problem |
| 2014-05-16 | Malfunction | None | Signal Artifact/Noise, Pacing Problem, Device-Device Incompatibility |
| 2014-05-16 | Injury | None | Over-Sensing |
| 2014-05-15 | Injury | None | Pacing Problem, Pacing Asynchronously |
| 2014-05-13 | Injury | None | High impedance |
| 2014-05-13 | Injury | None | Over-Sensing, Pacing Problem |
| 2014-05-08 | Malfunction | None | Failure to Capture, Mechanical Problem |
| 2014-05-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-05-07 | Injury | None | Pacing Problem |
| 2014-05-02 | Injury | None | Pacing Problem |
| 2014-05-02 | Malfunction | None | Pacing Problem |
| 2014-05-02 | Injury | None | Pacing Problem |
| 2014-04-25 | Injury | None | Pacing Problem |
| 2014-04-22 | Injury | None | Pacing Problem |
| 2014-04-20 | Injury | None | Failure to Capture, Pacing Problem |
| 2014-04-17 | Injury | None | Pacing Problem |
| 2014-04-16 | Malfunction | None | Battery Problem |
| 2014-04-15 | Malfunction | None | Data Problem |
| 2014-04-14 | Malfunction | None | Data Problem |
| 2014-04-10 | Malfunction | None | Under-Sensing |
| 2014-04-01 | Injury | None | Over-Sensing, Pacing Problem |
| 2014-03-31 | Malfunction | None | Battery Problem |
| 2014-03-24 | Injury | None | Pacing Problem |
| 2014-03-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-03-13 | Injury | None | Over-Sensing, Output Problem |
| 2014-03-11 | Injury | None | Pacing Problem |
| 2014-03-10 | Malfunction | None | Appropriate Term/Code Not Available |
| 2014-03-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-03-06 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2014-03-04 | Malfunction | None | Over-Sensing, Pacing Problem |
| 2014-03-03 | Malfunction | None | Pacing Problem |
| 2014-02-20 | Injury | None | Pacing Problem, Device Sensing Problem, Impedance Problem |
| 2014-02-20 | Injury | None | Pacing Problem |
| 2014-02-19 | Injury | None | Mechanical Problem |
| 2014-02-18 | Injury | None | Pacing Problem, Under-Sensing |
| 2014-02-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-02-14 | Injury | None | Unable to Obtain Readings |
| 2014-02-14 | Injury | None | Device Contamination with Body Fluid |
| 2014-02-12 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2014-02-12 | Malfunction | None | Mechanical Problem |
| 2014-02-03 | Injury | None | Over-Sensing, Pacing Problem |
| 2014-01-31 | Injury | None | Capturing Problem |
| 2014-01-30 | Malfunction | None | Premature Discharge of Battery, Unable to Obtain Readings |
| 2014-01-28 | Injury | None | Reset Problem |
| 2014-01-25 | Injury | None | Unable to Obtain Readings |
| 2014-01-25 | Malfunction | None | Pacing Problem |
| 2014-01-20 | Injury | None | Pacing Problem |
| 2014-01-16 | Injury | None | Over-Sensing, Pacing Problem |
| 2014-01-13 | Injury | None | Migration or Expulsion of Device, Device Contamination with Body Fluid |
| 2014-01-11 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-10 | Malfunction | None | Device-Device Incompatibility |
| 2014-01-06 | Malfunction | None | Over-Sensing, Pacing Problem, Under-Sensing |
| 2014-01-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-12-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-12-20 | Malfunction | None | Over-Sensing |
| 2013-12-19 | Malfunction | None | Mechanical Problem |
| 2013-12-19 | Injury | None | Mechanical Problem, Device Dislodged or Dislocated |
| 2013-12-18 | Injury | None | Mechanical Problem |
| 2013-12-13 | Malfunction | None | Premature Discharge of Battery |
| 2013-12-10 | Injury | None | Failure to Capture |
| 2013-12-10 | Injury | None | None |
| 2013-12-03 | Injury | None | Pacing Problem |
| 2013-11-29 | Injury | None | Pacing Problem |
| 2013-11-21 | Injury | None | High impedance |
| 2013-11-18 | Malfunction | None | Unable to Obtain Readings, Battery Problem |
| 2013-11-12 | Injury | None | Over-Sensing |
| 2013-11-12 | Injury | None | Pacing Problem |
| 2013-11-12 | Malfunction | None | Battery Problem |
| 2013-11-08 | Injury | None | Under-Sensing, Capturing Problem |
| 2013-11-07 | Injury | None | Pacing Problem |
| 2013-11-06 | Malfunction | None | Pacing Problem |
| 2013-10-31 | Injury | None | Over-Sensing |
| 2013-10-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-10-24 | Malfunction | None | Unable to Obtain Readings |
| 2013-10-23 | Injury | None | None |
| 2013-10-22 | Injury | None | Pacing Problem |
| 2013-10-21 | Injury | None | None |
| 2013-10-16 | Injury | None | None |
| 2013-10-15 | Injury | None | Pacing Problem |
| 2013-10-15 | Injury | None | None |
| 2013-10-14 | Malfunction | None | Pacing Problem |
| 2013-10-09 | Malfunction | None | None |
| 2013-10-07 | Malfunction | None | None |
| 2013-10-03 | Malfunction | None | Programming Issue |
| 2013-09-30 | Injury | None | None |
| 2013-09-30 | Injury | None | None |
| 2013-09-28 | Injury | None | Pacing Problem |
| 2013-09-24 | Injury | None | None |
| 2013-09-23 | Injury | None | None |
| 2013-09-23 | Injury | None | None |
| 2013-09-19 | Injury | None | None |
| 2013-09-18 | Injury | None | None |
| 2013-09-05 | Injury | None | None |
| 2013-08-30 | Injury | None | None |
| 2013-08-27 | Injury | None | None |
| 2013-08-26 | Malfunction | None | None |
| 2013-08-25 | Injury | None | None |
| 2013-08-25 | Malfunction | None | None |
| 2013-08-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-08-15 | Death | None | None |
| 2013-08-01 | Injury | None | None |
| 2013-07-15 | Injury | None | None |
| 2013-07-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-07-09 | Injury | None | None |
| 2013-07-07 | Injury | None | None |
| 2013-07-06 | Death | None | None |
| 2013-07-02 | Malfunction | None | None |
| 2013-07-01 | Malfunction | None | None |
| 2013-06-18 | Injury | None | None |
| 2013-06-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-06-04 | Injury | None | None |
| 2013-05-23 | Injury | None | None |
| 2013-05-23 | Injury | None | None |
| 2013-05-21 | Injury | None | None |
| 2013-05-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2013-05-15 | Injury | None | None |
| 2013-05-13 | Injury | None | None |
| 2013-05-13 | Injury | None | None |
| 2013-05-12 | Injury | None | None |
| 2013-05-07 | Malfunction | None | None |
| 2013-03-28 | Malfunction | None | None |
| 2013-03-22 | Malfunction | None | None |
| 2013-03-20 | Injury | None | None |
| 2013-03-15 | Injury | None | Appropriate Term/Code Not Available |
| 2013-03-14 | Injury | None | None |
| 2013-03-12 | Malfunction | None | None |
| 2013-03-11 | Injury | None | None |
| 2013-03-08 | Injury | None | None |
| 2013-03-05 | Malfunction | None | None |
| 2013-03-05 | Death | None | None |
| 2013-03-01 | Injury | None | None |
| 2013-02-26 | Malfunction | None | None |
| 2013-02-22 | Injury | None | None |
| 2013-02-21 | Malfunction | None | None |
| 2013-02-18 | Malfunction | None | None |
| 2013-02-13 | Malfunction | None | None |
| 2013-02-13 | Injury | None | None |
| 2013-02-07 | Malfunction | None | None |
| 2013-02-04 | Injury | None | None |
| 2013-01-17 | Injury | None | None |
| 2013-01-15 | Injury | None | None |
| 2013-01-04 | Injury | None | None |
| 2012-12-19 | Malfunction | None | None |
| 2012-12-17 | Injury | None | None |
| 2012-12-12 | Malfunction | None | None |
| 2012-12-03 | Injury | None | None |
| 2012-12-03 | Malfunction | None | None |
| 2012-11-29 | Injury | None | None |
| 2012-11-29 | Injury | None | None |
| 2012-11-23 | Malfunction | None | None |
| 2012-11-14 | Malfunction | None | None |
| 2012-11-07 | Injury | None | None |
| 2012-11-05 | Malfunction | None | None |
| 2012-10-15 | Injury | None | None |
| 2012-10-15 | Injury | None | None |
| 2012-10-15 | Injury | None | None |
| 2012-10-10 | Malfunction | None | None |
| 2012-10-08 | Malfunction | None | None |
| 2012-10-04 | Injury | None | None |
| 2012-10-03 | Injury | None | None |
| 2012-09-26 | Malfunction | None | None |
| 2012-09-12 | Malfunction | None | None |
| 2012-09-11 | Injury | None | None |
| 2012-09-01 | Injury | None | None |
| 2012-08-27 | Malfunction | None | Battery Problem |
| 2012-08-21 | Injury | None | None |
| 2012-08-15 | Malfunction | None | None |
| 2012-08-14 | Malfunction | None | None |
| 2012-08-14 | Injury | None | None |
| 2012-08-13 | Malfunction | None | None |
| 2012-07-09 | Injury | None | None |
| 2012-04-30 | Injury | None | None |
| 2012-04-16 | Malfunction | None | None |
| 2012-04-16 | Malfunction | None | None |
| 2012-04-11 | Malfunction | None | None |
| 2012-03-28 | Injury | None | None |
| 2012-03-19 | Malfunction | None | None |
| 2012-03-16 | Death | None | None |
| 2012-03-12 | Malfunction | None | None |
| 2012-02-25 | Injury | None | None |
| 2012-02-23 | Injury | None | None |
| 2012-02-19 | Injury | None | None |
| 2012-02-16 | Malfunction | None | None |
| 2012-02-15 | Malfunction | None | None |
| 2012-01-25 | Injury | None | None |
| 2012-01-12 | Injury | None | None |
| 2011-12-14 | Injury | None | None |
| 2011-12-14 | Malfunction | None | None |
| 2011-12-14 | Malfunction | None | None |
| 2011-12-13 | Malfunction | None | None |
| 2011-11-11 | Malfunction | None | None |
| 2011-10-27 | Malfunction | None | None |
| 2011-10-13 | Injury | None | None |
| 2011-10-13 | Malfunction | None | None |
| 2011-10-12 | Malfunction | None | None |
| 2011-09-28 | Injury | None | None |
| 2011-09-13 | Malfunction | None | None |
| 2011-09-09 | Malfunction | None | None |
| 2011-09-06 | Injury | None | None |
| 2011-08-23 | Malfunction | None | None |
| 2011-08-19 | Injury | None | None |
| 2011-08-11 | Malfunction | None | None |
| 2011-07-27 | Injury | None | None |
| 2011-06-17 | Injury | None | None |
| 2011-06-16 | Malfunction | None | None |
| 2011-06-15 | Malfunction | None | None |
| 2011-06-14 | Malfunction | None | None |
| 2011-06-06 | Malfunction | None | None |
| 2011-05-30 | Malfunction | None | None |
| 2011-05-01 | Injury | None | None |
| 2011-04-19 | Malfunction | None | None |
| 2011-04-14 | Malfunction | None | None |
| 2011-04-13 | Malfunction | None | None |
| 2011-03-10 | Malfunction | None | None |
| 2011-02-28 | Malfunction | None | None |
| 2011-02-09 | Malfunction | None | None |
| 2011-02-03 | Injury | None | None |
| 2011-01-05 | Malfunction | None | None |
| 2010-12-08 | Malfunction | None | None |
| 2008-05-08 | Malfunction | None | Mechanical Problem |