IMPLANTABLE PACEMAKER PULSE GENERATOR
This device is manufactured by ABBOTT, ABBOTT CRM, COOK MEDICAL, MEDTRONIC, ST JUDE MEDICAL and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Incorrect Measurement | 1 | Device |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2023 | Output Problem | 1 | Device |
| 2023 | Loose or Intermittent Connection | 1 | Device |
| 2023 | Failure to Disconnect | 2 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2022 | Failure to Capture | 1 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2019 | Signal Artifact/Noise | 1 | Device |
| 2019 | Separation Failure | 1 | Device |
| 2019 | Premature Discharge of Battery | 2 | Device |
| 2019 | Pacing Problem | 1 | Device |
| 2019 | Pacemaker Found in Back-Up Mode | 7 | Device |
| 2019 | Over-Sensing | 1 | Device |
| 2019 | No Pacing | 1 | Device |
| 2019 | Misconnection | 2 | Device |
| 2019 | Incorrect Measurement | 2 | Device |
| 2019 | High impedance | 1 | Device |
| 2019 | Failure to Interrogate | 9 | Device |
| 2019 | Failure to Capture | 1 | Device |
| 2019 | Device Sensing Problem | 1 | Device |
| 2019 | Data Problem | 7 | Device |
| 2019 | Connection Problem | 1 | Device |
| 2019 | Communication or Transmission Problem | 1 | Device |
| 2019 | Capturing Problem | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2018 | Signal Artifact/Noise | 1 | Device |
| 2018 | Premature Elective Replacement Indicator | 1 | Device |
| 2018 | Premature Discharge of Battery | 1 | Device |
| 2018 | Pacing Problem | 1 | Device |
| 2018 | Pacemaker Found in Back-Up Mode | 12 | Device |
| 2018 | No Pacing | 2 | Device |
| 2018 | Misconnection | 1 | Device |
| 2018 | Inappropriate or Unexpected Reset | 2 | Device |
| 2018 | Failure to Interrogate | 6 | Device |
| 2018 | Failure to Capture | 1 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Difficult to Interrogate | 1 | Device |
| 2018 | Device Displays Incorrect Message | 2 | Device |
| 2018 | Data Problem | 9 | Device |
| 2018 | Connection Problem | 2 | Device |
| 2018 | Communication or Transmission Problem | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2017 | Wireless Communication Problem | 1 | Device |
| 2017 | Under-Sensing | 1 | Device |
| 2017 | Telemetry Discrepancy | 1 | Device |
| 2017 | Premature Elective Replacement Indicator | 1 | Device |
| 2017 | Premature Discharge of Battery | 5 | Device |
| 2017 | Pacing Problem | 2 | Device |
| 2017 | Pacemaker Found in Back-Up Mode | 15 | Device |
| 2017 | Over-Sensing | 2 | Device |
| 2017 | Output Problem | 1 | Device |
| 2017 | No Device Output | 2 | Device |
| 2017 | Mechanical Problem | 2 | Device |
| 2017 | Low impedance | 1 | Device |
| 2017 | Incorrect Measurement | 2 | Device |
| 2017 | Inappropriate or Unexpected Reset | 6 | Device |
| 2017 | High impedance | 1 | Device |
| 2017 | Failure to Sense | 1 | Device |
| 2017 | Failure to Interrogate | 9 | Device |
| 2017 | Failure to Capture | 2 | Device |
| 2017 | Difficult to Remove | 2 | Device |
| 2017 | Difficult to Open or Close | 1 | Device |
| 2017 | Difficult to Interrogate | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 5 | Device |
| 2017 | Device Displays Incorrect Message | 4 | Device |
| 2017 | Data Problem | 5 | Device |
| 2017 | Connection Problem | 1 | Device |
| 2017 | Communication or Transmission Problem | 1 | Device |
| 2017 | Battery Impedance Issue | 1 | Device |
| 2017 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2016 | Telemetry Discrepancy | 2 | Device |
| 2016 | Premature Elective Replacement Indicator | 2 | Device |
| 2016 | Premature Discharge of Battery | 5 | Device |
| 2016 | Pacing Problem | 1 | Device |
| 2016 | Pacemaker Found in Back-Up Mode | 24 | Device |
| 2016 | Over-Sensing | 8 | Device |
| 2016 | No Device Output | 1 | Device |
| 2016 | Mechanical Problem | 1 | Device |
| 2016 | Loss of Data | 1 | Device |
| 2016 | Invalid Sensing | 1 | Device |
| 2016 | Increased Sensitivity | 1 | Device |
| 2016 | Inappropriate or Unexpected Reset | 3 | Device |
| 2016 | High Capture Threshold | 1 | Device |
| 2016 | Failure to Interrogate | 8 | Device |
| 2016 | Difficult to Remove | 2 | Device |
| 2016 | Device Operates Differently Than Expected | 18 | Device |
| 2016 | Device Displays Incorrect Message | 2 | Device |
| 2016 | Communication or Transmission Problem | 1 | Device |
| 2016 | Capturing Problem | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Pacemaker Found in Back-Up Mode | 8 | Device |
| 2015 | No Device Output | 2 | Device |
| 2015 | Difficult to Interrogate | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 5 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2014 | Under-Sensing | 1 | Device |
| 2014 | Telemetry Discrepancy | 2 | Device |
| 2014 | Premature End-of-Life Indicator | 1 | Device |
| 2014 | Premature Elective Replacement Indicator | 1 | Device |
| 2014 | Premature Discharge of Battery | 3 | Device |
| 2014 | Pacing Problem | 3 | Device |
| 2014 | Pacing Intermittently | 1 | Device |
| 2014 | Pacing Inadequately | 1 | Device |
| 2014 | Pacemaker Found in Back-Up Mode | 38 | Device |
| 2014 | Over-Sensing | 1 | Device |
| 2014 | Output Problem | 2 | Device |
| 2014 | No Device Output | 9 | Device |
| 2014 | Mechanical Problem | 1 | Device |
| 2014 | Loss of Data | 1 | Device |
| 2014 | Failure to Interrogate | 13 | Device |
| 2014 | Difficult to Remove | 1 | Device |
| 2014 | Difficult to Interrogate | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 20 | Device |
| 2014 | Device Displays Incorrect Message | 5 | Device |
| 2014 | Connection Problem | 1 | Device |
| 2014 | Communication or Transmission Problem | 1 | Device |
| 2014 | Cautery | 1 | Device |
| 2014 | Break | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2013 | Insufficient Information | 1 | Patient |
| 2013 | Under-Sensing | 1 | Device |
| 2013 | Telemetry Discrepancy | 2 | Device |
| 2013 | Premature Elective Replacement Indicator | 2 | Device |
| 2013 | Premature Discharge of Battery | 2 | Device |
| 2013 | Pacing Problem | 1 | Device |
| 2013 | Pacemaker Found in Back-Up Mode | 27 | Device |
| 2013 | Output Problem | 3 | Device |
| 2013 | No Device Output | 5 | Device |
| 2013 | Migration or Expulsion of Device | 1 | Device |
| 2013 | Improper Device Output | 1 | Device |
| 2013 | High Capture Threshold | 2 | Device |
| 2013 | Failure to Interrogate | 1 | Device |
| 2013 | Failure to Capture | 2 | Device |
| 2013 | Device Operates Differently Than Expected | 8 | Device |
| 2013 | Device Displays Incorrect Message | 4 | Device |
| 2013 | Connection Problem | 1 | Device |
| 2013 | Capturing Problem | 2 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2012 | Premature Elective Replacement Indicator | 1 | Device |
| 2012 | Pacing Problem | 1 | Device |
| 2012 | Pacemaker Found in Back-Up Mode | 13 | Device |
| 2012 | Output Problem | 2 | Device |
| 2012 | Failure to Sense | 1 | Device |
| 2012 | Failure to Capture | 1 | Device |
| 2012 | Device Operates Differently Than Expected | 2 | Device |
| 2011 | Unspecified Infection | 1 | Patient |
| 2011 | Pacemaker Found in Back-Up Mode | 4 | Device |
| 2011 | Over-Sensing | 1 | Device |
| 2011 | Intermittent Capture | 1 | Device |
| 2011 | Insufficient Information | 1 | Device |
| 2011 | Failure to Interrogate | 2 | Device |
| 2011 | Device Operates Differently Than Expected | 4 | Device |
| 2011 | Device Displays Incorrect Message | 1 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2005 | High Capture Threshold | 1 | Device |
| 2004 | Telemetry Discrepancy | 1 | Device |
| 2004 | No Pacing | 1 | Device |