IMPLANTABLE PACEMAKER PULSE GENERATOR
This device is manufactured by ABBOTT, ABBOTT CRM, ST JUDE MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR) and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2024 | Failure to Interrogate | 1 | Device |
| 2023 | Premature Discharge of Battery | 1 | Device |
| 2023 | Pacemaker Found in Back-Up Mode | 2 | Device |
| 2023 | No Pacing | 1 | Device |
| 2023 | Failure to Interrogate | 1 | Device |
| 2022 | Premature Discharge of Battery | 1 | Device |
| 2022 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2022 | Failure to Interrogate | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | Fracture | 1 | Device |
| 2019 | Telemetry Discrepancy | 1 | Device |
| 2019 | Separation Failure | 1 | Device |
| 2019 | Premature Discharge of Battery | 19 | Device |
| 2019 | Pacing Problem | 1 | Device |
| 2019 | Pacing Intermittently | 1 | Device |
| 2019 | Pacemaker Found in Back-Up Mode | 17 | Device |
| 2019 | No Pacing | 1 | Device |
| 2019 | Misconnection | 2 | Device |
| 2019 | Incorrect Measurement | 2 | Device |
| 2019 | Inappropriate or Unexpected Reset | 4 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2019 | Fitting Problem | 1 | Device |
| 2019 | Failure to Interrogate | 11 | Device |
| 2019 | Data Problem | 2 | Device |
| 2019 | Communication or Transmission Problem | 1 | Device |
| 2019 | Battery Problem: Low Impedance | 1 | Device |
| 2019 | Appropriate Term/Code Not Available | 3 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2018 | Telemetry Discrepancy | 1 | Device |
| 2018 | Premature Elective Replacement Indicator | 3 | Device |
| 2018 | Premature Discharge of Battery | 19 | Device |
| 2018 | Pacing Problem | 1 | Device |
| 2018 | Pacemaker Found in Back-Up Mode | 23 | Device |
| 2018 | Output Problem | 1 | Device |
| 2018 | Out-Of-Box Failure | 1 | Device |
| 2018 | Misconnection | 1 | Device |
| 2018 | Incorrect Measurement | 1 | Device |
| 2018 | Inappropriate or Unexpected Reset | 2 | Device |
| 2018 | High impedance | 3 | Device |
| 2018 | High Capture Threshold | 2 | Device |
| 2018 | Fitting Problem | 2 | Device |
| 2018 | Failure to Interrogate | 11 | Device |
| 2018 | Failure to Capture | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Device Displays Incorrect Message | 1 | Device |
| 2018 | Decreased Sensitivity | 1 | Device |
| 2018 | Data Problem | 4 | Device |
| 2018 | Battery Problem: High Impedance | 3 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2017 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2017 | Telemetry Discrepancy | 3 | Device |
| 2017 | Premature Elective Replacement Indicator | 6 | Device |
| 2017 | Premature Discharge of Battery | 34 | Device |
| 2017 | Pacing Problem | 1 | Device |
| 2017 | Pacing Intermittently | 1 | Device |
| 2017 | Pacemaker Found in Back-Up Mode | 40 | Device |
| 2017 | Output Problem | 2 | Device |
| 2017 | No Device Output | 4 | Device |
| 2017 | Mechanical Problem | 1 | Device |
| 2017 | Intermittent Capture | 1 | Device |
| 2017 | Incorrect Measurement | 4 | Device |
| 2017 | Inappropriate or Unexpected Reset | 11 | Device |
| 2017 | High Capture Threshold | 1 | Device |
| 2017 | Failure to Interrogate | 14 | Device |
| 2017 | Difficult to Remove | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 6 | Device |
| 2017 | Data Problem | 1 | Device |
| 2017 | Capturing Problem | 1 | Device |
| 2017 | Break | 1 | Device |
| 2017 | Battery Problem: High Impedance | 1 | Device |
| 2017 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2016 | Under-Sensing | 1 | Device |
| 2016 | Telemetry Discrepancy | 3 | Device |
| 2016 | Programming Issue | 1 | Device |
| 2016 | Premature Elective Replacement Indicator | 4 | Device |
| 2016 | Premature Discharge of Battery | 17 | Device |
| 2016 | Pacing Problem | 2 | Device |
| 2016 | Pacemaker Found in Back-Up Mode | 33 | Device |
| 2016 | Over-Sensing | 4 | Device |
| 2016 | Output Problem | 1 | Device |
| 2016 | No Pacing | 1 | Device |
| 2016 | No Device Output | 3 | Device |
| 2016 | Mechanical Problem | 1 | Device |
| 2016 | Inappropriate or Unexpected Reset | 6 | Device |
| 2016 | High impedance | 3 | Device |
| 2016 | Failure to Sense | 1 | Device |
| 2016 | Failure to Interrogate | 8 | Device |
| 2016 | Failure to Capture | 1 | Device |
| 2016 | Difficult to Interrogate | 1 | Device |
| 2016 | Difficult to Insert | 2 | Device |
| 2016 | Device Operates Differently Than Expected | 8 | Device |
| 2016 | Device Displays Incorrect Message | 1 | Device |
| 2016 | Battery Problem | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2015 | Telemetry Discrepancy | 4 | Device |
| 2015 | Premature Discharge of Battery | 5 | Device |
| 2015 | Pacemaker Found in Back-Up Mode | 9 | Device |
| 2015 | Out-Of-Box Failure | 1 | Device |
| 2015 | No Device Output | 3 | Device |
| 2015 | Intermittent Capture | 1 | Device |
| 2015 | Impedance Problem | 1 | Device |
| 2015 | Failure to Interrogate | 6 | Device |
| 2015 | Difficult to Insert | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 2 | Device |
| 2015 | Device Displays Incorrect Message | 2 | Device |
| 2015 | Component Falling | 1 | Device |
| 2015 | Break | 1 | Device |
| 2015 | Battery Problem | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2014 | Telemetry Discrepancy | 4 | Device |
| 2014 | Premature Elective Replacement Indicator | 6 | Device |
| 2014 | Premature Discharge of Battery | 7 | Device |
| 2014 | Pacemaker Found in Back-Up Mode | 17 | Device |
| 2014 | Over-Sensing | 1 | Device |
| 2014 | Output Problem | 1 | Device |
| 2014 | No Device Output | 5 | Device |
| 2014 | Mechanical Problem | 2 | Device |
| 2014 | Incorrect Measurement | 1 | Device |
| 2014 | Impedance Problem | 1 | Device |
| 2014 | High impedance | 1 | Device |
| 2014 | Failure to Sense | 1 | Device |
| 2014 | Failure to Interrogate | 9 | Device |
| 2014 | Failure to Capture | 2 | Device |
| 2014 | Difficult to Interrogate | 1 | Device |
| 2014 | Difficult to Insert | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 12 | Device |
| 2014 | Device Displays Incorrect Message | 2 | Device |
| 2014 | Communication or Transmission Problem | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2013 | Premature End-of-Life Indicator | 3 | Device |
| 2013 | Premature Elective Replacement Indicator | 9 | Device |
| 2013 | Premature Discharge of Battery | 9 | Device |
| 2013 | Pacemaker Found in Back-Up Mode | 18 | Device |
| 2013 | Over-Sensing | 1 | Device |
| 2013 | No Device Output | 3 | Device |
| 2013 | Incorrect Measurement | 2 | Device |
| 2013 | Image Display Error/Artifact | 1 | Device |
| 2013 | High impedance | 2 | Device |
| 2013 | Failure to Interrogate | 4 | Device |
| 2013 | Failure to Capture | 1 | Device |
| 2013 | Device Sensing Problem | 1 | Device |
| 2013 | Device Operates Differently Than Expected | 7 | Device |
| 2013 | Device Inoperable | 1 | Device |
| 2013 | Device Damaged Prior to Use | 1 | Device |
| 2013 | Capturing Problem | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2012 | Pacemaker Found in Back-Up Mode | 3 | Device |
| 2012 | Failure to Interrogate | 1 | Device |
| 2012 | Device Operates Differently Than Expected | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2011 | Insufficient Information | 2 | Patient |
| 2011 | Premature Elective Replacement Indicator | 1 | Device |
| 2011 | Material Erosion | 1 | Device |
| 2011 | High Capture Threshold | 1 | Device |
| 2011 | Failure to Capture | 1 | Device |
| 2011 | Device Operates Differently Than Expected | 1 | Device |