PERMANENT PACEMAKER ELECTRODE
This device is manufactured by ABBOTT MEDICAL, ABBOTT MEDICAL / ST JUDE MEDICAL, ST JUDE MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE).
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 2 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Failure of Implant | 7 | Patient |
| 2023 | Pacing Problem | 1 | Device |
| 2023 | Over-Sensing | 3 | Device |
| 2023 | Output Problem | 3 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | Fracture | 1 | Device |
| 2022 | Ventricular Fibrillation | 1 | Patient |
| 2022 | Unspecified Infection | 12 | Patient |
| 2022 | Syncope/Fainting | 2 | Patient |
| 2022 | Shock from Patient Lead(s) | 2 | Patient |
| 2022 | Sepsis | 2 | Patient |
| 2022 | Pocket Erosion | 1 | Patient |
| 2022 | Insufficient Information | 3 | Patient |
| 2022 | Head Injury | 1 | Patient |
| 2022 | Failure of Implant | 7 | Patient |
| 2022 | Bradycardia | 1 | Patient |
| 2022 | Asystole | 1 | Patient |
| 2022 | Under-Sensing | 2 | Device |
| 2022 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2022 | Signal Artifact/Noise | 9 | Device |
| 2022 | Pacing Problem | 4 | Device |
| 2022 | Over-Sensing | 9 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | Low impedance | 4 | Device |
| 2022 | Intermittent Capture | 1 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2022 | Impedance Problem | 9 | Device |
| 2022 | High impedance | 2 | Device |
| 2022 | High Capture Threshold | 3 | Device |
| 2022 | Failure to Capture | 4 | Device |
| 2022 | Energy Output Problem | 2 | Device |
| 2022 | Electromagnetic Interference | 1 | Device |
| 2022 | Disconnection | 1 | Device |
| 2022 | Defective Device | 4 | Device |
| 2022 | Defective Component | 7 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2021 | Unspecified Infection | 9 | Patient |
| 2021 | Sepsis | 3 | Patient |
| 2021 | Insufficient Information | 77 | Patient |
| 2021 | Fall | 1 | Patient |
| 2021 | Dizziness | 2 | Patient |
| 2021 | Arrhythmia | 2 | Patient |
| 2021 | Under-Sensing | 9 | Device |
| 2021 | Therapeutic or Diagnostic Output Failure | 5 | Device |
| 2021 | Signal Artifact/Noise | 24 | Device |
| 2021 | Pacing Inadequately | 2 | Device |
| 2021 | Pacemaker Found in Back-Up Mode | 2 | Device |
| 2021 | Over-Sensing | 13 | Device |
| 2021 | Output Problem | 1 | Device |
| 2021 | No Pacing | 3 | Device |
| 2021 | Microbial Contamination of Device | 2 | Device |
| 2021 | Material Integrity Problem | 3 | Device |
| 2021 | Low impedance | 11 | Device |
| 2021 | Loose or Intermittent Connection | 1 | Device |
| 2021 | Intermittent Continuity | 1 | Device |
| 2021 | Insufficient Information | 17 | Device |
| 2021 | Impedance Problem | 18 | Device |
| 2021 | High impedance | 7 | Device |
| 2021 | High Capture Threshold | 6 | Device |
| 2021 | Fracture | 1 | Device |
| 2021 | Failure to Capture | 7 | Device |
| 2021 | Electrical /Electronic Property Problem | 2 | Device |
| 2021 | Display or Visual Feedback Problem | 1 | Device |
| 2021 | Device Sensing Problem | 2 | Device |
| 2021 | Device Dislodged or Dislocated | 1 | Device |
| 2021 | Computer Software Problem | 1 | Device |
| 2021 | Battery Problem | 2 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Visual Impairment | 1 | Patient |
| 2020 | Unspecified Infection | 3 | Patient |
| 2020 | Swelling/ Edema | 1 | Patient |
| 2020 | Insufficient Information | 22 | Patient |
| 2020 | Dyspnea | 1 | Patient |
| 2020 | Arrhythmia | 6 | Patient |
| 2020 | Under-Sensing | 3 | Device |
| 2020 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2020 | Signal Artifact/Noise | 4 | Device |
| 2020 | Product Quality Problem | 1 | Device |
| 2020 | Pacing Problem | 1 | Device |
| 2020 | Over-Sensing | 8 | Device |
| 2020 | Noise, Audible | 2 | Device |
| 2020 | Material Integrity Problem | 1 | Device |
| 2020 | Low impedance | 3 | Device |
| 2020 | Insufficient Information | 4 | Device |
| 2020 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2020 | Impedance Problem | 5 | Device |
| 2020 | High impedance | 2 | Device |
| 2020 | High Sensing Threshold | 1 | Device |
| 2020 | High Capture Threshold | 1 | Device |
| 2020 | Failure to Capture | 1 | Device |
| 2020 | Display or Visual Feedback Problem | 1 | Device |
| 2020 | Defective Component | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2019 | Unspecified Infection | 3 | Patient |
| 2019 | Shock from Patient Lead(s) | 1 | Patient |
| 2019 | Presyncope | 1 | Patient |
| 2019 | Insufficient Information | 13 | Patient |
| 2019 | Foreign Body In Patient | 1 | Patient |
| 2019 | Discomfort | 1 | Patient |
| 2019 | Arrhythmia | 1 | Patient |
| 2019 | Appropriate Term / Code Not Available | 1 | Patient |
| 2019 | Under-Sensing | 1 | Device |
| 2019 | Therapeutic or Diagnostic Output Failure | 2 | Device |
| 2019 | Signal Artifact/Noise | 11 | Device |
| 2019 | Pacing Problem | 1 | Device |
| 2019 | Pacemaker Found in Back-Up Mode | 2 | Device |
| 2019 | Over-Sensing | 9 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Material Erosion | 1 | Device |
| 2019 | Low impedance | 6 | Device |
| 2019 | Insufficient Information | 12 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2019 | Impedance Problem | 6 | Device |
| 2019 | Image Display Error/Artifact | 1 | Device |
| 2019 | High impedance | 5 | Device |
| 2019 | High Sensing Threshold | 2 | Device |
| 2019 | High Capture Threshold | 1 | Device |
| 2019 | Failure to Capture | 1 | Device |
| 2019 | Device Sensing Problem | 1 | Device |
| 2018 | Unspecified Infection | 10 | Patient |
| 2018 | Shock from Patient Lead(s) | 1 | Patient |
| 2018 | Pocket Erosion | 3 | Patient |
| 2018 | Insufficient Information | 32 | Patient |
| 2018 | Hematoma | 1 | Patient |
| 2018 | Foreign Body In Patient | 11 | Patient |
| 2018 | Device Overstimulation of Tissue | 1 | Patient |
| 2018 | Arrhythmia | 1 | Patient |
| 2018 | Under-Sensing | 1 | Device |
| 2018 | Therapeutic or Diagnostic Output Failure | 8 | Device |
| 2018 | Signal Artifact/Noise | 11 | Device |
| 2018 | Product Quality Problem | 4 | Device |
| 2018 | Pocket Stimulation | 1 | Device |
| 2018 | Physical Resistance/Sticking | 1 | Device |
| 2018 | Pacing Intermittently | 1 | Device |
| 2018 | Pacing Inadequately | 2 | Device |
| 2018 | Pacemaker Found in Back-Up Mode | 4 | Device |
| 2018 | Over-Sensing | 7 | Device |
| 2018 | Output Problem | 1 | Device |
| 2018 | No Pacing | 4 | Device |
| 2018 | Mechanical Problem | 1 | Device |
| 2018 | Material Erosion | 2 | Device |
| 2018 | Low impedance | 5 | Device |
| 2018 | Insufficient Information | 5 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2018 | Impedance Problem | 6 | Device |
| 2018 | High impedance | 4 | Device |
| 2018 | High Capture Threshold | 1 | Device |
| 2018 | Fracture | 4 | Device |
| 2018 | Failure to Sense | 1 | Device |
| 2018 | Failure to Capture | 4 | Device |
| 2018 | Electrical /Electronic Property Problem | 1 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Device Sensing Problem | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2017 | Unspecified Infection | 29 | Patient |
| 2017 | Sepsis | 2 | Patient |
| 2017 | Pocket Erosion | 4 | Patient |
| 2017 | Insufficient Information | 50 | Patient |
| 2017 | Foreign Body In Patient | 1 | Patient |
| 2017 | Cardiac Arrest | 1 | Patient |
| 2017 | Use of Device Problem | 4 | Device |
| 2017 | Under-Sensing | 2 | Device |
| 2017 | Therapeutic or Diagnostic Output Failure | 2 | Device |
| 2017 | Signal Artifact/Noise | 15 | Device |
| 2017 | Short Fill | 1 | Device |
| 2017 | Product Quality Problem | 4 | Device |
| 2017 | Pacing Problem | 5 | Device |
| 2017 | Pacing Inadequately | 2 | Device |
| 2017 | Pacemaker Found in Back-Up Mode | 3 | Device |
| 2017 | Over-Sensing | 13 | Device |
| 2017 | Nonstandard Device | 3 | Device |
| 2017 | No Pacing | 6 | Device |
| 2017 | Material Erosion | 1 | Device |
| 2017 | Low impedance | 1 | Device |
| 2017 | Insufficient Information | 18 | Device |
| 2017 | Incorrect Interpretation of Signal | 1 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2017 | Impedance Problem | 6 | Device |
| 2017 | High impedance | 1 | Device |
| 2017 | High Sensing Threshold | 1 | Device |
| 2017 | High Capture Threshold | 2 | Device |
| 2017 | Fracture | 2 | Device |
| 2017 | Failure to Capture | 2 | Device |
| 2017 | Electrical /Electronic Property Problem | 2 | Device |
| 2017 | Device Sensing Problem | 2 | Device |
| 2017 | Device Dislodged or Dislocated | 1 | Device |
| 2017 | Defibrillation/Stimulation Problem | 2 | Device |
| 2017 | Defective Device | 2 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 14 | Device |
| 2016 | Syncope/Fainting | 1 | Patient |
| 2016 | Insufficient Information | 7 | Patient |
| 2016 | Foreign Body In Patient | 7 | Patient |
| 2016 | Emotional Changes | 1 | Patient |
| 2016 | Device Overstimulation of Tissue | 1 | Patient |
| 2016 | Use of Device Problem | 2 | Device |
| 2016 | Therapeutic or Diagnostic Output Failure | 4 | Device |
| 2016 | Signal Artifact/Noise | 5 | Device |
| 2016 | Product Quality Problem | 1 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2016 | High impedance | 1 | Device |
| 2016 | High Capture Threshold | 1 | Device |
| 2016 | Fracture | 2 | Device |
| 2016 | Failure to Sense | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2014 | Unspecified Infection | 2 | Patient |
| 2014 | Tachycardia | 1 | Patient |
| 2014 | Syncope/Fainting | 1 | Patient |
| 2014 | Presyncope | 1 | Patient |
| 2014 | Pocket Erosion | 1 | Patient |
| 2014 | Insufficient Information | 20 | Patient |
| 2014 | Foreign Body In Patient | 8 | Patient |
| 2014 | Device Overstimulation of Tissue | 1 | Patient |
| 2014 | Appropriate Term / Code Not Available | 1 | Patient |
| 2014 | Under-Sensing | 4 | Device |
| 2014 | Therapeutic or Diagnostic Output Failure | 3 | Device |
| 2014 | Signal Artifact/Noise | 1 | Device |
| 2014 | Pacing Problem | 1 | Device |
| 2014 | Noise, Audible | 1 | Device |
| 2014 | Migration or Expulsion of Device | 1 | Device |
| 2014 | Material Deformation | 1 | Device |
| 2014 | Insufficient Information | 9 | Device |
| 2014 | Impedance Problem | 2 | Device |
| 2014 | High impedance | 5 | Device |
| 2014 | High Sensing Threshold | 2 | Device |
| 2014 | High Capture Threshold | 1 | Device |
| 2014 | Fracture | 1 | Device |
| 2014 | Failure to Capture | 3 | Device |
| 2014 | Device Sensing Problem | 2 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2013 | Unspecified Infection | 25 | Patient |
| 2013 | Undesired Nerve Stimulation | 1 | Patient |
| 2013 | Syncope/Fainting | 1 | Patient |
| 2013 | Shock from Patient Lead(s) | 2 | Patient |
| 2013 | Pocket Erosion | 3 | Patient |
| 2013 | Perforation | 1 | Patient |
| 2013 | Insufficient Information | 89 | Patient |
| 2013 | Foreign Body In Patient | 11 | Patient |
| 2013 | Endocarditis | 1 | Patient |
| 2013 | Dizziness | 2 | Patient |
| 2013 | Cardiac Arrest | 1 | Patient |
| 2013 | Atrial Flutter | 1 | Patient |
| 2013 | Appropriate Term / Code Not Available | 1 | Patient |
| 2013 | Use of Device Problem | 9 | Device |
| 2013 | Under-Sensing | 5 | Device |
| 2013 | Therapeutic or Diagnostic Output Failure | 21 | Device |
| 2013 | Signal Artifact/Noise | 16 | Device |
| 2013 | Product Quality Problem | 1 | Device |
| 2013 | Premature Discharge of Battery | 1 | Device |
| 2013 | Pacing Problem | 4 | Device |
| 2013 | Pacing Intermittently | 1 | Device |
| 2013 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2013 | Over-Sensing | 5 | Device |
| 2013 | Operating System Version or Upgrade Problem | 2 | Device |
| 2013 | No Pacing | 2 | Device |
| 2013 | Naturally Worn | 1 | Device |
| 2013 | Mechanical Problem | 1 | Device |
| 2013 | Material Integrity Problem | 1 | Device |
| 2013 | Material Erosion | 2 | Device |
| 2013 | Low impedance | 3 | Device |
| 2013 | Loss of Threshold | 2 | Device |
| 2013 | Insufficient Information | 23 | Device |
| 2013 | Incorrect Interpretation of Signal | 1 | Device |
| 2013 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2013 | Inappropriate or Unexpected Reset | 2 | Device |
| 2013 | Impedance Problem | 4 | Device |
| 2013 | High impedance | 3 | Device |
| 2013 | High Sensing Threshold | 4 | Device |
| 2013 | High Capture Threshold | 9 | Device |
| 2013 | Fracture | 2 | Device |
| 2013 | Failure to Capture | 7 | Device |
| 2013 | Electrical /Electronic Property Problem | 1 | Device |
| 2013 | Device Sensing Problem | 1 | Device |
| 2013 | Device Dislodged or Dislocated | 1 | Device |
| 2013 | Break | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 27 | Device |
| 2012 | Unspecified Infection | 15 | Patient |
| 2012 | Syncope/Fainting | 1 | Patient |
| 2012 | Shock from Patient Lead(s) | 1 | Patient |
| 2012 | Pericarditis | 1 | Patient |
| 2012 | Myocardial Infarction | 1 | Patient |
| 2012 | Insufficient Information | 56 | Patient |
| 2012 | Hip Fracture | 1 | Patient |
| 2012 | Foreign Body In Patient | 11 | Patient |
| 2012 | Endocarditis | 1 | Patient |
| 2012 | Dizziness | 1 | Patient |
| 2012 | Discomfort | 1 | Patient |
| 2012 | Atrial Fibrillation | 2 | Patient |
| 2012 | Therapeutic or Diagnostic Output Failure | 15 | Device |
| 2012 | Signal Artifact/Noise | 9 | Device |
| 2012 | Scratched Material | 1 | Device |
| 2012 | Premature Discharge of Battery | 1 | Device |
| 2012 | Pacing Problem | 2 | Device |
| 2012 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2012 | Over-Sensing | 2 | Device |
| 2012 | Operating System Version or Upgrade Problem | 1 | Device |
| 2012 | No Pacing | 2 | Device |
| 2012 | Material Erosion | 1 | Device |
| 2012 | Low impedance | 7 | Device |
| 2012 | Insufficient Information | 21 | Device |
| 2012 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2012 | Impedance Problem | 1 | Device |
| 2012 | High impedance | 1 | Device |
| 2012 | High Capture Threshold | 4 | Device |
| 2012 | Fracture | 3 | Device |
| 2012 | Failure to Capture | 11 | Device |
| 2012 | Device Sensing Problem | 3 | Device |
| 2012 | Break | 7 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2011 | Unspecified Infection | 18 | Patient |
| 2011 | Twiddlers Syndrome | 2 | Patient |
| 2011 | Pocket Erosion | 5 | Patient |
| 2011 | Obstruction/Occlusion | 1 | Patient |
| 2011 | Insufficient Information | 85 | Patient |
| 2011 | Foreign Body In Patient | 3 | Patient |
| 2011 | Dizziness | 2 | Patient |
| 2011 | Bacterial Infection | 2 | Patient |
| 2011 | Arrhythmia | 1 | Patient |
| 2011 | Under-Sensing | 3 | Device |
| 2011 | Therapeutic or Diagnostic Output Failure | 13 | Device |
| 2011 | Signal Artifact/Noise | 11 | Device |
| 2011 | Product Quality Problem | 6 | Device |
| 2011 | Positioning Problem | 1 | Device |
| 2011 | Pacing Problem | 3 | Device |
| 2011 | Over-Sensing | 5 | Device |
| 2011 | Off-Label Use | 1 | Device |
| 2011 | No Pacing | 1 | Device |
| 2011 | Migration | 2 | Device |
| 2011 | Mechanical Problem | 3 | Device |
| 2011 | Material Erosion | 1 | Device |
| 2011 | Low impedance | 3 | Device |
| 2011 | Low Sensing Threshold | 1 | Device |
| 2011 | Insufficient Information | 9 | Device |
| 2011 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2011 | Impedance Problem | 9 | Device |
| 2011 | High impedance | 8 | Device |
| 2011 | High Capture Threshold | 7 | Device |
| 2011 | Fracture | 4 | Device |
| 2011 | Failure to Sense | 1 | Device |
| 2011 | Failure to Capture | 2 | Device |
| 2011 | Expulsion | 1 | Device |
| 2011 | Entrapment of Device | 1 | Device |
| 2011 | Display or Visual Feedback Problem | 1 | Device |
| 2011 | Difficult to Remove | 4 | Device |
| 2011 | Difficult to Insert | 1 | Device |
| 2011 | Device Fell | 1 | Device |
| 2011 | Device Dislodged or Dislocated | 3 | Device |
| 2011 | Break | 3 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 24 | Device |
| 2011 | Activation, Positioning or Separation Problem | 1 | Device |
| 2010 | Pocket Erosion | 1 | Patient |
| 2010 | Insufficient Information | 3 | Patient |
| 2010 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2010 | Signal Artifact/Noise | 1 | Device |
| 2010 | Product Quality Problem | 1 | Device |
| 2010 | Material Erosion | 1 | Device |
| 2010 | Impedance Problem | 1 | Device |
| 2010 | High Capture Threshold | 1 | Device |
| 2008 | Unspecified Infection | 1 | Patient |
| 2008 | Insufficient Information | 1 | Device |
| 2007 | Foreign Body In Patient | 1 | Patient |
| 2007 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2005 | Unspecified Infection | 1 | Patient |
| 2005 | Insufficient Information | 1 | Patient |
| 2005 | High impedance | 1 | Device |
| 2005 | Difficult to Remove | 1 | Device |
| 2003 | Foreign Body In Patient | 1 | Patient |
| 2003 | High impedance | 1 | Device |
| 2002 | Insufficient Information | 1 | Patient |
| 2002 | Insufficient Information | 1 | Device |