IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
This device is manufactured by ABBOTT, ST JUDE MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR), ST JUDE MEDICAL - UNKNOWN and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2020 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2019 | Separation Failure | 1 | Device |
| 2019 | Premature Discharge of Battery | 2 | Device |
| 2019 | Misconnection | 1 | Device |
| 2019 | Incorrect Measurement | 1 | Device |
| 2019 | Incorrect Interpretation of Signal | 2 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2019 | High impedance | 1 | Device |
| 2019 | Failure to Interrogate | 1 | Device |
| 2019 | Failure to Charge | 1 | Device |
| 2019 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2018 | Under-Sensing | 3 | Device |
| 2018 | Separation Failure | 1 | Device |
| 2018 | Premature Elective Replacement Indicator | 1 | Device |
| 2018 | Premature Discharge of Battery | 14 | Device |
| 2018 | Over-Sensing | 5 | Device |
| 2018 | Misconnection | 2 | Device |
| 2018 | Loose or Intermittent Connection | 1 | Device |
| 2018 | Incorrect Measurement | 1 | Device |
| 2018 | Incorrect Interpretation of Signal | 3 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 9 | Device |
| 2018 | Inappropriate or Unexpected Reset | 3 | Device |
| 2018 | Impedance Problem | 1 | Device |
| 2018 | High impedance | 2 | Device |
| 2018 | Failure to Interrogate | 4 | Device |
| 2018 | Failure to Charge | 2 | Device |
| 2018 | Difficult to Remove | 4 | Device |
| 2018 | Device Sensing Problem | 1 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2018 | Detachment Of Device Component | 1 | Device |
| 2018 | Delayed Charge Time | 3 | Device |
| 2018 | Defibrillation/Stimulation Problem | 1 | Device |
| 2018 | Data Problem | 1 | Device |
| 2018 | Connection Problem | 3 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2017 | Under-Sensing | 2 | Device |
| 2017 | Telemetry Discrepancy | 1 | Device |
| 2017 | Signal Artifact/Noise | 2 | Device |
| 2017 | Premature End-of-Life Indicator | 2 | Device |
| 2017 | Premature Elective Replacement Indicator | 1 | Device |
| 2017 | Premature Discharge of Battery | 25 | Device |
| 2017 | Pacing Inadequately | 1 | Device |
| 2017 | Over-Sensing | 14 | Device |
| 2017 | Mechanical Problem | 2 | Device |
| 2017 | Incorrect Measurement | 4 | Device |
| 2017 | Incorrect Interpretation of Signal | 1 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 11 | Device |
| 2017 | Inappropriate or Unexpected Reset | 3 | Device |
| 2017 | Failure to Interrogate | 3 | Device |
| 2017 | Failure to Disconnect | 1 | Device |
| 2017 | Electromagnetic Interference | 1 | Device |
| 2017 | Difficult to Remove | 7 | Device |
| 2017 | Device Operates Differently Than Expected | 9 | Device |
| 2017 | Device Displays Incorrect Message | 2 | Device |
| 2017 | Device Alarm System | 3 | Device |
| 2017 | Detachment Of Device Component | 1 | Device |
| 2017 | Delayed Charge Time | 3 | Device |
| 2017 | Defibrillation/Stimulation Problem | 4 | Device |
| 2017 | Defective Alarm | 1 | Device |
| 2017 | Data Problem | 4 | Device |
| 2017 | Connection Problem | 4 | Device |
| 2017 | Charging Problem | 1 | Device |
| 2017 | Battery Problem | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2016 | Under-Sensing | 3 | Device |
| 2016 | Premature End-of-Life Indicator | 2 | Device |
| 2016 | Premature Elective Replacement Indicator | 1 | Device |
| 2016 | Premature Discharge of Battery | 10 | Device |
| 2016 | Pacing Problem | 1 | Device |
| 2016 | Pacing Inadequately | 1 | Device |
| 2016 | Over-Sensing | 5 | Device |
| 2016 | Output Problem | 1 | Device |
| 2016 | Low impedance | 1 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 11 | Device |
| 2016 | Inappropriate or Unexpected Reset | 3 | Device |
| 2016 | False Alarm | 1 | Device |
| 2016 | Failure to Interrogate | 3 | Device |
| 2016 | Failure to Convert Rhythm | 2 | Device |
| 2016 | Device Sensing Problem | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 7 | Device |
| 2016 | Delayed Charge Time | 2 | Device |
| 2016 | Decreased Sensitivity | 1 | Device |
| 2016 | Connection Problem | 1 | Device |
| 2016 | Break | 1 | Device |
| 2016 | Appropriate Term/Code Not Available | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2015 | Under-Sensing | 2 | Device |
| 2015 | Premature End-of-Life Indicator | 1 | Device |
| 2015 | Premature Elective Replacement Indicator | 2 | Device |
| 2015 | Premature Discharge of Battery | 3 | Device |
| 2015 | Over-Sensing | 2 | Device |
| 2015 | Inappropriate/Inadequate Shock/Stimulation | 5 | Device |
| 2015 | High impedance | 1 | Device |
| 2015 | Failure to Interrogate | 1 | Device |
| 2015 | Delayed Charge Time | 1 | Device |
| 2015 | Connection Problem | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2014 | Under-Sensing | 5 | Device |
| 2014 | Premature End-of-Life Indicator | 1 | Device |
| 2014 | Premature Elective Replacement Indicator | 5 | Device |
| 2014 | Premature Discharge of Battery | 5 | Device |
| 2014 | Over-Sensing | 15 | Device |
| 2014 | Output Problem | 3 | Device |
| 2014 | Inappropriate/Inadequate Shock/Stimulation | 18 | Device |
| 2014 | Inappropriate or Unexpected Reset | 5 | Device |
| 2014 | Impedance Problem | 1 | Device |
| 2014 | High impedance | 3 | Device |
| 2014 | Failure to Interrogate | 5 | Device |
| 2014 | Failure to Convert Rhythm | 4 | Device |
| 2014 | Electromagnetic Interference | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 4 | Device |
| 2014 | Delayed Charge Time | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2014 | Aborted Charge | 2 | Device |
| 2013 | Under-Sensing | 1 | Device |
| 2013 | Premature Discharge of Battery | 2 | Device |
| 2013 | Over-Sensing | 6 | Device |
| 2013 | Output Problem | 2 | Device |
| 2013 | Low impedance | 2 | Device |
| 2013 | Intermittent Capture | 1 | Device |
| 2013 | Inappropriate/Inadequate Shock/Stimulation | 11 | Device |
| 2013 | Inappropriate or Unexpected Reset | 2 | Device |
| 2013 | Impedance Problem | 2 | Device |
| 2013 | High impedance | 1 | Device |
| 2013 | High Capture Threshold | 1 | Device |
| 2013 | Failure to Interrogate | 1 | Device |
| 2013 | Electromagnetic Interference | 2 | Device |
| 2013 | Device Operates Differently Than Expected | 3 | Device |
| 2013 | Delayed Charge Time | 2 | Device |
| 2013 | Decreased Sensitivity | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2012 | Under-Sensing | 3 | Device |
| 2012 | Over-Sensing | 14 | Device |
| 2012 | Output Problem | 4 | Device |
| 2012 | Low impedance | 1 | Device |
| 2012 | Inappropriate/Inadequate Shock/Stimulation | 13 | Device |
| 2012 | Inappropriate or Unexpected Reset | 2 | Device |
| 2012 | Impedance Problem | 1 | Device |
| 2012 | High impedance | 1 | Device |
| 2012 | Failure to Interrogate | 2 | Device |
| 2012 | Difficult to Interrogate | 1 | Device |
| 2012 | Device Operates Differently Than Expected | 4 | Device |
| 2012 | Device Displays Incorrect Message | 1 | Device |
| 2012 | Defibrillation/Stimulation Problem | 1 | Device |
| 2012 | Connection Problem | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2011 | Undesired Nerve Stimulation | 1 | Patient |
| 2011 | Under-Sensing | 2 | Device |
| 2011 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2011 | Premature End-of-Life Indicator | 1 | Device |
| 2011 | Pacing Problem | 1 | Device |
| 2011 | Over-Sensing | 13 | Device |
| 2011 | Output Problem | 2 | Device |
| 2011 | Low impedance | 1 | Device |
| 2011 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2011 | Inappropriate or Unexpected Reset | 1 | Device |
| 2011 | High impedance | 3 | Device |
| 2011 | Difficult to Interrogate | 1 | Device |
| 2011 | Delayed Charge Time | 1 | Device |
| 2011 | Connection Problem | 2 | Device |
| 2010 | Over-Sensing | 1 | Device |
| 2010 | Output Problem | 1 | Device |
| 2010 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2010 | Failure to Charge | 1 | Device |
| 2008 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |