PACEMAKER PROGRAMMER
This device is manufactured by ABBOTT, ST JUDE MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR), ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-05-25 | Injury | Arrhythmia | Failure to Interrogate |
| 2024-02-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2024-02-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2024-02-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2024-01-09 | Injury | Syncope/Fainting | Program or Algorithm Execution Failure |
| 2023-11-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2023-10-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Thermal Decomposition of Device |
| 2023-10-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2023-10-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Smoking, Unexpected Shutdown |
| 2023-09-22 | Malfunction | Insufficient Information | Defective Device |
| 2023-09-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Program or Algorithm Execution Failure |
| 2023-09-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Thermal Decomposition of Device |
| 2023-07-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2023-07-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Melted |
| 2023-06-15 | Injury | Arrhythmia | Unexpected Shutdown |
| 2023-06-15 | Malfunction | Discomfort | Noise, Audible, Unintended Electrical Shock |
| 2023-06-13 | Malfunction | Dizziness | Data Problem |
| 2023-06-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2023-05-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2023-02-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2023-02-23 | Injury | Arrhythmia | Failure to Deliver Shock/Stimulation, Application Program Freezes, Becomes Nonfunctional |
| 2022-12-27 | Injury | Discomfort | Unintended Electrical Shock |
| 2022-12-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2022-10-24 | Malfunction | None | Failure to Power Up, Smoking |
| 2022-09-26 | Malfunction | None | Incorrect Measurement |
| 2022-08-31 | Malfunction | None | Incorrect Measurement |
| 2022-08-30 | Malfunction | None | Incorrect Measurement |
| 2022-08-23 | Malfunction | None | Incorrect Measurement |
| 2022-08-08 | Malfunction | None | Incorrect Measurement |
| 2022-08-01 | Malfunction | None | Incorrect Measurement |
| 2022-07-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect Measurement |
| 2022-07-14 | Malfunction | None | Incorrect Measurement |
| 2022-07-12 | Malfunction | None | Incorrect Measurement |
| 2022-07-06 | Malfunction | None | Incorrect Measurement |
| 2022-06-26 | Malfunction | None | Incorrect Measurement |
| 2022-05-12 | Malfunction | None | Incorrect Measurement |
| 2022-04-13 | Malfunction | None | Failure to Interrogate |
| 2022-04-08 | Malfunction | None | Failure to Interrogate |
| 2022-04-08 | Malfunction | None | Failure to Interrogate |
| 2022-03-31 | Malfunction | None | Failure to Interrogate |
| 2022-03-30 | Malfunction | None | Failure to Interrogate |
| 2022-03-29 | Malfunction | None | Failure to Interrogate |
| 2022-03-28 | Malfunction | None | Unintended Electrical Shock |
| 2022-03-16 | Malfunction | None | Program or Algorithm Execution Failure |
| 2022-03-16 | Malfunction | None | Program or Algorithm Execution Failure |
| 2022-03-15 | Injury | None | Program or Algorithm Execution Failure |
| 2022-03-11 | Malfunction | None | Program or Algorithm Execution Failure |
| 2022-03-08 | Malfunction | None | Unintended Electrical Shock |
| 2021-11-22 | Injury | None | Incorrect Measurement |
| 2021-11-05 | Malfunction | None | Incorrect Measurement |
| 2021-08-25 | Malfunction | None | Incorrect Measurement |
| 2021-07-28 | Malfunction | None | Incorrect, Inadequate or Imprecise Result or Readings, Application Program Freezes, Becomes Nonfunctional |
| 2021-07-16 | Malfunction | None | Incorrect Measurement |
| 2021-04-22 | Malfunction | None | Program or Algorithm Execution Failure |
| 2021-04-19 | Malfunction | None | Program or Algorithm Execution Failure |
| 2019-10-28 | Malfunction | None | Computer Software Problem |
| 2019-09-04 | Malfunction | None | Computer Software Problem, Intermittent Communication Failure |
| 2019-08-25 | Malfunction | None | Display or Visual Feedback Problem, Sparking |
| 2019-07-30 | Malfunction | None | Thermal Decomposition of Device |
| 2019-07-24 | Malfunction | None | No Pacing, Wireless Communication Problem |
| 2019-07-02 | Malfunction | None | Failure to Power Up, Sparking |
| 2019-05-16 | Malfunction | None | Data Problem |
| 2019-04-30 | Injury | Discomfort | Adverse Event Without Identified Device or Use Problem, Unintended Electrical Shock |
| 2019-04-29 | Malfunction | None | Thermal Decomposition of Device |
| 2019-03-28 | Malfunction | None | Incorrect Measurement |
| 2019-03-26 | Malfunction | None | Incorrect Measurement |
| 2019-03-06 | Malfunction | None | Incorrect Measurement |
| 2019-03-01 | Injury | None | Incorrect Measurement |
| 2019-03-01 | Malfunction | None | Data Problem |
| 2019-02-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-13 | Malfunction | None | Incorrect Measurement |
| 2019-02-05 | Injury | None | Incorrect Measurement |
| 2019-01-31 | Malfunction | None | Incorrect Measurement |
| 2019-01-23 | Malfunction | None | Failure to Power Up |
| 2019-01-16 | Malfunction | None | Incorrect Measurement |
| 2019-01-16 | Malfunction | None | Incorrect Measurement |
| 2019-01-15 | Malfunction | None | Incorrect Measurement |
| 2019-01-14 | Malfunction | None | Temperature Problem |
| 2018-12-21 | Malfunction | None | Incorrect Measurement |
| 2018-11-27 | Malfunction | None | Sparking |
| 2018-11-27 | Malfunction | None | Incorrect Measurement |
| 2018-11-27 | Malfunction | None | Incorrect Measurement |
| 2018-11-26 | Malfunction | None | Incorrect Measurement |
| 2018-11-26 | Malfunction | None | Data Problem |
| 2018-11-26 | Malfunction | None | Data Problem |
| 2018-11-15 | Malfunction | None | Incorrect Measurement |
| 2018-11-09 | Malfunction | None | Incorrect Measurement |
| 2018-11-08 | Malfunction | None | Data Problem |
| 2018-11-05 | Malfunction | None | Incorrect Measurement |
| 2018-11-01 | Malfunction | None | Data Problem |
| 2018-10-30 | Malfunction | None | Smoking, Noise, Audible |
| 2018-10-11 | Malfunction | None | Data Problem |
| 2018-10-10 | Malfunction | None | Incorrect Measurement |
| 2018-10-05 | Malfunction | None | Incorrect Measurement |
| 2018-10-05 | Malfunction | None | Failure to Read Input Signal |
| 2018-10-04 | Malfunction | None | Thermal Decomposition of Device |
| 2018-09-28 | Injury | None | Incorrect Measurement |
| 2018-09-27 | Injury | None | Incorrect Measurement |
| 2018-09-21 | Malfunction | None | Incorrect Measurement |
| 2018-09-10 | Malfunction | None | Incorrect Measurement |
| 2018-09-03 | Injury | None | Incorrect Measurement |
| 2018-08-29 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-28 | Malfunction | None | Thermal Decomposition of Device |
| 2018-08-27 | Malfunction | None | Incorrect Measurement |
| 2018-08-15 | Malfunction | None | Data Problem |
| 2018-07-17 | Malfunction | None | Incorrect Measurement |
| 2018-07-03 | Malfunction | None | Data Problem |
| 2018-07-02 | Malfunction | None | Data Problem |
| 2018-06-30 | Malfunction | None | Incorrect Measurement |
| 2018-06-22 | Malfunction | None | Data Problem |
| 2018-06-20 | Malfunction | None | Unintended Electrical Shock |
| 2018-06-14 | Malfunction | None | Incorrect Measurement |
| 2018-06-05 | Injury | None | Incorrect Measurement |
| 2018-05-30 | Malfunction | None | No Display/Image |
| 2018-05-29 | Malfunction | None | Thermal Decomposition of Device |
| 2018-05-15 | Malfunction | None | Incorrect Measurement |
| 2018-05-14 | Malfunction | None | Incorrect Measurement |
| 2018-05-11 | Malfunction | None | Incorrect Measurement |
| 2018-05-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-05-08 | Malfunction | None | Data Problem |
| 2018-05-02 | Malfunction | None | Data Problem |
| 2018-04-30 | Malfunction | None | Incorrect Measurement |
| 2018-04-27 | Malfunction | None | Incorrect Measurement |
| 2018-04-23 | Malfunction | None | Incorrect Measurement |
| 2018-04-12 | Malfunction | None | Incorrect Measurement |
| 2018-04-11 | Malfunction | None | Incorrect Measurement |
| 2018-04-11 | Malfunction | None | Incorrect Measurement |
| 2018-04-09 | Malfunction | None | Incorrect Measurement |
| 2018-04-05 | Malfunction | None | Incorrect Measurement |
| 2018-04-04 | Malfunction | None | Data Problem |
| 2018-03-30 | Malfunction | None | Incorrect Measurement |
| 2018-03-29 | Malfunction | None | Incorrect Measurement |
| 2018-03-28 | Malfunction | None | Incorrect Measurement |
| 2018-03-27 | Malfunction | None | Data Problem |
| 2018-03-27 | Malfunction | None | Incorrect Measurement |
| 2018-03-22 | Malfunction | None | Incorrect Measurement |
| 2018-03-21 | Malfunction | None | Incorrect Measurement |
| 2018-03-19 | Malfunction | None | Incorrect Measurement |
| 2018-03-16 | Malfunction | None | Incorrect Measurement |
| 2018-03-15 | Malfunction | None | Incorrect Measurement |
| 2018-03-13 | Malfunction | None | Incorrect Measurement |
| 2018-03-02 | Malfunction | None | Incorrect Measurement |
| 2018-02-26 | Malfunction | None | Incorrect Measurement |
| 2018-02-15 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-02-09 | Malfunction | None | Incorrect Measurement |
| 2018-02-09 | Malfunction | None | Incorrect Measurement |
| 2018-02-06 | Malfunction | None | Incorrect Measurement |
| 2018-02-01 | Malfunction | None | Overheating of Device, Failure to Power Up, Noise, Audible |
| 2018-01-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-24 | Malfunction | None | Data Problem |
| 2018-01-23 | Malfunction | None | Incorrect Measurement |
| 2018-01-22 | Malfunction | None | Incorrect Measurement |
| 2018-01-18 | Malfunction | None | Incorrect Measurement |
| 2018-01-18 | Malfunction | None | Data Problem |
| 2018-01-10 | Injury | None | Incorrect Measurement |
| 2018-01-09 | Malfunction | None | Incorrect Measurement |
| 2018-01-09 | Malfunction | None | Data Problem |
| 2018-01-04 | Malfunction | None | Thermal Decomposition of Device, Charred |
| 2017-12-22 | Malfunction | None | Incorrect Measurement |
| 2017-12-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-12-19 | Malfunction | None | Data Problem |
| 2017-12-15 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-12-15 | Malfunction | None | Incorrect Measurement |
| 2017-12-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-12-06 | Malfunction | None | Incorrect Measurement |
| 2017-12-06 | Malfunction | None | Incorrect Measurement |
| 2017-12-06 | Malfunction | None | Incorrect Measurement |
| 2017-12-05 | Injury | None | Incorrect Measurement |
| 2017-12-01 | Malfunction | None | Data Problem |
| 2017-11-30 | Malfunction | None | Incorrect Measurement |
| 2017-11-30 | Malfunction | None | Incorrect Measurement |
| 2017-11-30 | Malfunction | None | Incorrect Measurement |
| 2017-11-30 | Malfunction | None | Incorrect Measurement |
| 2017-11-29 | Malfunction | None | Overheating of Device, Device Operates Differently Than Expected |
| 2017-11-20 | Malfunction | None | Thermal Decomposition of Device |
| 2017-11-16 | Malfunction | None | Incorrect Measurement |
| 2017-11-14 | Malfunction | None | Incorrect Software Programming Calculations |
| 2017-11-13 | Malfunction | None | Incorrect Measurement |
| 2017-11-11 | Malfunction | None | Data Problem |
| 2017-11-10 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-11-10 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-11-07 | Malfunction | None | Incorrect Measurement |
| 2017-11-05 | Injury | None | Loose or Intermittent Connection |
| 2017-11-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-11-02 | Malfunction | None | Incorrect Measurement |
| 2017-10-31 | Malfunction | None | Thermal Decomposition of Device, Failure to Power Up |
| 2017-10-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-10-26 | Malfunction | None | Premature Discharge of Battery, Incorrect Measurement |
| 2017-10-26 | Malfunction | None | Thermal Decomposition of Device |
| 2017-10-23 | Malfunction | None | Incorrect Measurement |
| 2017-10-18 | Malfunction | None | Wireless Communication Problem |
| 2017-10-13 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-10-12 | Malfunction | None | Overheating of Device |
| 2017-10-10 | Malfunction | None | Incorrect Measurement |
| 2017-10-10 | Malfunction | None | Incorrect Measurement |
| 2017-10-10 | Injury | None | Telemetry Discrepancy |
| 2017-10-02 | Malfunction | None | Incorrect Measurement |
| 2017-10-02 | Malfunction | None | Incorrect Measurement |
| 2017-09-29 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-28 | Injury | None | Incorrect Measurement |
| 2017-09-21 | Malfunction | None | Incorrect Measurement |
| 2017-09-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-09-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-09-02 | Malfunction | None | Data Problem |
| 2017-08-31 | Malfunction | None | Incorrect Measurement |
| 2017-08-28 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-23 | Malfunction | None | Incorrect Software Programming Calculations |
| 2017-08-23 | Malfunction | None | Thermal Decomposition of Device |
| 2017-08-19 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-08-15 | Malfunction | None | Incorrect Measurement |
| 2017-08-15 | Malfunction | None | Data Problem |
| 2017-08-15 | Malfunction | None | Incorrect Measurement |
| 2017-08-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-08-10 | Malfunction | None | Incorrect Software Programming Calculations |
| 2017-08-09 | Malfunction | None | Data Problem |
| 2017-08-06 | Malfunction | None | Incorrect Measurement |
| 2017-08-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-08-02 | Malfunction | None | Incorrect Measurement |
| 2017-07-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-07-26 | Malfunction | None | Incorrect Measurement |
| 2017-07-26 | Malfunction | None | Incorrect Measurement |
| 2017-07-19 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-07-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-07-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-07-05 | Malfunction | None | Incorrect Measurement, Device Operates Differently Than Expected |
| 2017-07-02 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-30 | Malfunction | None | Data Problem |
| 2017-06-30 | Malfunction | None | Data Problem |
| 2017-06-27 | Malfunction | None | Incorrect Measurement |
| 2017-06-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-26 | Malfunction | None | Incorrect Measurement |
| 2017-06-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-19 | Injury | None | Incorrect Measurement |
| 2017-06-19 | Malfunction | None | Data Problem |
| 2017-06-16 | Malfunction | None | Incorrect Measurement |
| 2017-06-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-14 | Malfunction | None | Incorrect Measurement |
| 2017-06-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-08 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-06 | Malfunction | None | Data Problem |
| 2017-06-06 | Injury | None | Computer Operating System Problem, No Pacing |
| 2017-06-05 | Malfunction | None | Incorrect Measurement |
| 2017-06-01 | Malfunction | None | Data Problem |
| 2017-06-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-01 | Malfunction | None | Incorrect Measurement |
| 2017-05-31 | Malfunction | None | Incorrect Measurement |
| 2017-05-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-26 | Malfunction | None | Incorrect Measurement |
| 2017-05-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-23 | Malfunction | None | Incorrect Measurement |
| 2017-05-20 | Injury | None | Device Operates Differently Than Expected |
| 2017-05-19 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-19 | Injury | None | Communication or Transmission Problem |
| 2017-05-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-15 | Malfunction | None | Failure to Interrogate, Telemetry Discrepancy, Device Operates Differently Than Expected |
| 2017-05-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-10 | Malfunction | None | Incorrect Measurement |
| 2017-05-04 | Malfunction | None | Wireless Communication Problem |
| 2017-05-04 | Malfunction | None | Incorrect Measurement |
| 2017-05-02 | Malfunction | None | Incorrect Measurement |
| 2017-05-02 | Malfunction | None | Thermal Decomposition of Device |
| 2017-04-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-28 | Malfunction | None | Display or Visual Feedback Problem |
| 2017-04-27 | Malfunction | None | Data Problem |
| 2017-04-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-26 | Malfunction | None | Incorrect Measurement |
| 2017-04-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-25 | Malfunction | None | Incorrect Measurement |
| 2017-04-25 | Malfunction | None | Incorrect Measurement |
| 2017-04-21 | Malfunction | None | Data Problem |
| 2017-04-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-20 | Malfunction | None | Incorrect Measurement |
| 2017-04-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-18 | Injury | None | Incorrect Measurement |
| 2017-04-17 | Malfunction | None | Data Problem |
| 2017-04-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-12 | Injury | None | Incorrect Measurement |
| 2017-04-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-06 | Malfunction | None | Incorrect Measurement |
| 2017-04-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-04 | Malfunction | None | Data Problem |
| 2017-04-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-03 | Malfunction | None | Data Problem |
| 2017-04-03 | Malfunction | None | Incorrect Measurement |
| 2017-04-01 | Malfunction | None | Data Problem |
| 2017-04-01 | Malfunction | None | Incorrect Measurement |
| 2017-03-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-29 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-24 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-24 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-17 | Injury | None | Electro-Static Discharge |
| 2017-03-16 | Malfunction | None | Incorrect Measurement |
| 2017-03-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-15 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-09 | Injury | None | Incorrect Measurement |
| 2017-03-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-02 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-28 | Malfunction | None | Incorrect Software Programming Calculations |
| 2017-02-27 | Injury | None | Incorrect Measurement |
| 2017-02-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-24 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-23 | Malfunction | None | Device Operates Differently Than Expected, Data Problem |
| 2017-02-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-16 | Malfunction | None | Therapeutic or Diagnostic Output Failure |
| 2017-02-14 | Malfunction | None | Data Problem |
| 2017-02-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-10 | Malfunction | None | Incorrect Measurement |
| 2017-02-10 | Malfunction | None | Data Problem |
| 2017-02-08 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-02 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-01 | Malfunction | None | Measurement System Incompatibility |
| 2017-02-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-27 | Malfunction | None | Device Emits Odor, Loss of Power, Computer Operating System Problem |
| 2017-01-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-24 | Malfunction | None | Thermal Decomposition of Device, Failure to Power Up, Noise, Audible |
| 2017-01-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-23 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2017-01-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-20 | Malfunction | None | Improper Device Output |
| 2017-01-19 | Malfunction | None | Improper Device Output |
| 2017-01-18 | Malfunction | None | Display or Visual Feedback Problem |
| 2017-01-18 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-16 | Malfunction | None | Incorrect Measurement |
| 2017-01-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-13 | Malfunction | None | Data Problem |
| 2017-01-12 | Malfunction | None | Data Problem |
| 2017-01-11 | Injury | None | Therapeutic or Diagnostic Output Failure |
| 2017-01-10 | Malfunction | None | Improper Device Output |
| 2017-01-05 | Malfunction | None | Data Problem |
| 2017-01-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-30 | Malfunction | None | Incorrect Measurement, Device Operates Differently Than Expected |
| 2016-12-28 | Malfunction | None | Incorrect Measurement |
| 2016-12-23 | Injury | None | Incorrect Measurement |
| 2016-12-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-16 | Malfunction | None | Data Problem |
| 2016-12-13 | Malfunction | None | Improper Device Output |
| 2016-12-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-12 | Malfunction | None | No Pacing |
| 2016-12-10 | Malfunction | None | Incorrect Measurement |
| 2016-12-08 | Malfunction | None | Thermal Decomposition of Device, Display or Visual Feedback Problem, Device Emits Odor |
| 2016-12-08 | Malfunction | None | Data Problem |
| 2016-12-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-06 | Malfunction | None | Incorrect Measurement |
| 2016-12-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-01 | Injury | None | Data Problem |
| 2016-12-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-30 | Malfunction | None | Incorrect Software Programming Calculations |
| 2016-11-29 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-28 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-28 | Malfunction | None | Telemetry Discrepancy |
| 2016-11-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-25 | Malfunction | None | Data Problem |
| 2016-11-25 | Malfunction | None | Data Problem |
| 2016-11-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-23 | Malfunction | None | Improper Device Output |
| 2016-11-22 | Malfunction | None | Improper Device Output |
| 2016-11-21 | Malfunction | None | Improper Device Output |
| 2016-11-21 | Malfunction | None | Incorrect Software Programming Calculations |
| 2016-11-21 | Malfunction | None | Incorrect Measurement |
| 2016-11-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-18 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-18 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-18 | Malfunction | None | Display or Visual Feedback Problem |
| 2016-11-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-16 | Injury | None | Incorrect Measurement |
| 2016-11-15 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-14 | Malfunction | None | Data Problem |
| 2016-11-14 | Malfunction | None | Incorrect Software Programming Calculations |
| 2016-11-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-11 | Malfunction | None | Thermal Decomposition of Device, Charred, Overheating of Device |
| 2016-11-11 | Malfunction | None | Incorrect Software Programming Calculations |
| 2016-11-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-10 | Malfunction | None | Incorrect Measurement |
| 2016-11-09 | Malfunction | None | Incorrect Measurement |
| 2016-11-08 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-07 | Injury | None | Incorrect Measurement |
| 2016-11-04 | Malfunction | None | Data Problem |
| 2016-11-01 | Malfunction | None | Data Problem |
| 2016-11-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-01 | Malfunction | None | Incorrect Measurement |
| 2016-10-31 | Malfunction | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2016-10-31 | Malfunction | None | Incorrect Measurement |
| 2016-10-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-10-27 | Malfunction | None | Computer Software Problem |
| 2016-10-27 | Injury | None | Therapeutic or Diagnostic Output Failure |
| 2016-10-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-10-25 | Malfunction | None | Improper Device Output |
| 2016-10-24 | Malfunction | None | Incorrect Measurement |
| 2016-10-24 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-10-24 | Malfunction | None | Incorrect Measurement |
| 2016-10-22 | Malfunction | None | Incorrect Software Programming Calculations |
| 2016-10-21 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2016-10-19 | Malfunction | None | Overheating of Device |
| 2016-10-19 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-17 | Malfunction | None | Measurement System Incompatibility |
| 2016-10-17 | Injury | None | Device Operates Differently Than Expected |
| 2016-10-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-10-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-10-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-10-06 | Malfunction | None | Improper Device Output |
| 2016-10-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-10-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-10-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-10-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-29 | Malfunction | None | Incorrect Software Programming Calculations |
| 2016-09-28 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-28 | Malfunction | None | Appropriate Term/Code Not Available |
| 2016-09-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-27 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-09-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-22 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-22 | Malfunction | None | Data Problem |
| 2016-09-21 | Injury | None | Premature Discharge of Battery |
| 2016-09-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-19 | Malfunction | None | Data Problem |
| 2016-09-19 | Malfunction | None | Improper Device Output |
| 2016-09-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-12 | Malfunction | None | Improper Device Output |
| 2016-09-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-08 | Malfunction | None | Improper Device Output |
| 2016-09-08 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-08 | Malfunction | None | Charred |
| 2016-09-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-07 | Malfunction | None | Improper Device Output |
| 2016-09-06 | Malfunction | None | Improper Device Output |
| 2016-09-05 | Malfunction | None | Incorrect Measurement |
| 2016-09-01 | Malfunction | None | Improper Device Output |
| 2016-08-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-25 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-24 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-23 | Malfunction | None | No Device Output, Application Program Problem |
| 2016-08-23 | Malfunction | None | Computer Software Problem |
| 2016-08-22 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-18 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-16 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-16 | Injury | None | Device Operates Differently Than Expected |
| 2016-08-16 | Malfunction | None | Failure to Capture, Failure to Sense |
| 2016-08-15 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2016-08-15 | Malfunction | None | Telemetry Discrepancy, Device Displays Incorrect Message |
| 2016-08-15 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-15 | Malfunction | None | Thermal Decomposition of Device, Overheating of Device |
| 2016-08-15 | Malfunction | None | Improper Device Output |
| 2016-08-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-08 | Malfunction | None | Data Problem |
| 2016-08-08 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-02 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-08-01 | Malfunction | None | Data Problem |
| 2016-08-01 | Malfunction | None | Data Problem |
| 2016-08-01 | Malfunction | None | Computer Software Problem |
| 2016-07-28 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-28 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-25 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-25 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-21 | Malfunction | None | Improper Device Output |
| 2016-07-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-21 | Malfunction | None | No Device Output, Power Problem |
| 2016-07-20 | Malfunction | None | Improper Device Output |
| 2016-07-19 | Malfunction | None | Improper Device Output |
| 2016-07-18 | Malfunction | None | Incorrect Measurement |
| 2016-07-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-12 | Malfunction | None | Battery Problem |
| 2016-07-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-30 | Malfunction | None | Thermal Decomposition of Device, Electrical /Electronic Property Problem |
| 2016-06-29 | Malfunction | None | Failure to Power Up, Noise, Audible |
| 2016-06-29 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-29 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-28 | Malfunction | None | Power Conditioning Problem, Noise, Audible |
| 2016-06-28 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-25 | Malfunction | None | Thermal Decomposition of Device |
| 2016-06-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-21 | Malfunction | None | Improper Device Output |
| 2016-06-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-15 | Malfunction | None | Improper Device Output |
| 2016-06-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-03 | Malfunction | None | Incorrect Measurement |
| 2016-05-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-05-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-05-18 | Malfunction | None | Improper Device Output |
| 2016-05-18 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-05-09 | Malfunction | None | Improper Device Output |
| 2016-05-02 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-05-02 | Malfunction | None | Premature Discharge of Battery |
| 2016-04-29 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-04-28 | Malfunction | None | Incorrect Measurement |
| 2016-04-28 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-04-22 | Malfunction | None | Data Problem |
| 2016-04-21 | Malfunction | None | Improper Device Output |
| 2016-04-21 | Malfunction | None | Incorrect Measurement |
| 2016-04-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-04-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-03-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-03-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-03-04 | Injury | None | Device Operates Differently Than Expected |
| 2016-02-29 | Malfunction | None | Improper Device Output |
| 2016-02-24 | Malfunction | None | Improper Device Output |
| 2016-02-19 | Malfunction | None | Incorrect Measurement |
| 2016-02-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-02-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-02-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-02-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-01-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-12-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-12-01 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-12-01 | Malfunction | None | Improper Device Output |
| 2015-08-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-08-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-07-14 | Malfunction | None | Incorrect Measurement |
| 2015-07-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-03-24 | Malfunction | None | Thermal Decomposition of Device, Device Emits Odor, Smoking |
| 2015-03-17 | Malfunction | None | Device Operates Differently Than Expected, Noise, Audible |
| 2015-02-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-02-24 | Malfunction | None | Thermal Decomposition of Device |
| 2015-01-15 | Injury | None | Device Operates Differently Than Expected |
| 2014-08-18 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-06-09 | Malfunction | None | Leak/Splash |
| 2014-05-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-04-30 | Injury | None | Device Operates Differently Than Expected |
| 2014-04-10 | Malfunction | None | Overheating of Device, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2014-04-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-03-18 | Malfunction | None | Device Emits Odor, Overheating of Device, Over-Sensing |
| 2014-02-24 | Malfunction | None | Break |
| 2014-02-24 | Malfunction | None | Smoking |
| 2014-02-11 | Malfunction | None | Device Emits Odor |
| 2014-01-28 | Injury | None | Electrical /Electronic Property Problem, Over-Sensing, Device Operates Differently Than Expected |
| 2014-01-27 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2014-01-14 | Malfunction | None | Device Emits Odor |
| 2014-01-09 | Malfunction | None | Device Emits Odor |
| 2013-12-19 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-12-18 | Malfunction | None | Device Emits Odor, Over-Sensing, Device Operates Differently Than Expected |
| 2013-08-19 | Injury | None | None |
| 2013-08-15 | Injury | None | None |
| 2013-04-29 | Malfunction | None | Difficult to Interrogate, Device Operates Differently Than Expected |
| 2013-04-05 | Malfunction | None | None |
| 2013-03-28 | Other | None | Programming Issue |
| 2013-03-25 | Malfunction | None | Telemetry Discrepancy |
| 2013-03-18 | Malfunction | None | None |
| 2013-03-07 | Other | None | Device Displays Incorrect Message |
| 2013-03-06 | Malfunction | None | Failure to Interrogate |
| 2013-03-05 | Malfunction | None | Telemetry Discrepancy |
| 2013-03-05 | Malfunction | None | Telemetry Discrepancy |
| 2013-03-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2012-11-20 | Malfunction | None | None |
| 2012-10-12 | Malfunction | None | None |
| 2012-06-28 | Malfunction | None | None |
| 2012-03-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2011-05-24 | Malfunction | None | None |
| 2011-05-23 | Malfunction | None | None |
| 2011-04-22 | Malfunction | None | None |
| 2011-04-05 | Malfunction | None | None |
| 2011-03-08 | Malfunction | None | None |
| 2011-03-08 | Injury | None | None |
| 2011-03-02 | Malfunction | None | None |
| 2010-12-14 | Malfunction | None | None |
| 2010-06-22 | Malfunction | None | None |
| 2010-02-25 | Malfunction | None | None |