DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
This device is manufactured by MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO, MEDTRONIC SA and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Failure to Charge | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 1 | Device |
| 2023 | Delayed Charge Time | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Reset Problem | 1 | Device |
| 2019 | Premature Discharge of Battery | 5 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2019 | Inappropriate or Unexpected Reset | 1 | Device |
| 2019 | Failure to Interrogate | 1 | Device |
| 2019 | Failure to Charge | 1 | Device |
| 2019 | Device Sensing Problem | 1 | Device |
| 2019 | Delayed Charge Time | 2 | Device |
| 2019 | Defibrillation/Stimulation Problem | 1 | Device |
| 2019 | Battery Problem | 2 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2018 | Unable to Obtain Readings | 1 | Device |
| 2018 | Protective Measures Problem | 3 | Device |
| 2018 | Premature Discharge of Battery | 9 | Device |
| 2018 | Pacing Problem | 1 | Device |
| 2018 | Over-Sensing | 2 | Device |
| 2018 | Noise, Audible | 1 | Device |
| 2018 | Migration or Expulsion of Device | 1 | Device |
| 2018 | Mechanical Problem | 1 | Device |
| 2018 | Invalid Sensing | 2 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2018 | Impedance Problem | 1 | Device |
| 2018 | Failure to Charge | 2 | Device |
| 2018 | Electromagnetic Interference | 1 | Device |
| 2018 | Electrical /Electronic Property Problem | 1 | Device |
| 2018 | Device Sensing Problem | 2 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Device Displays Incorrect Message | 1 | Device |
| 2018 | Delayed Charge Time | 6 | Device |
| 2018 | Defibrillation/Stimulation Problem | 1 | Device |
| 2018 | Communication or Transmission Problem | 1 | Device |
| 2018 | Charging Problem | 2 | Device |
| 2018 | Battery Problem: High Impedance | 2 | Device |
| 2018 | Battery Problem | 6 | Device |
| 2018 | Appropriate Term/Code Not Available | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2017 | Unable to Obtain Readings | 3 | Device |
| 2017 | Reset Problem | 2 | Device |
| 2017 | Protective Measures Problem | 3 | Device |
| 2017 | Premature Discharge of Battery | 16 | Device |
| 2017 | Pacing Problem | 2 | Device |
| 2017 | Over-Sensing | 3 | Device |
| 2017 | Output Problem | 1 | Device |
| 2017 | Migration or Expulsion of Device | 1 | Device |
| 2017 | Mechanical Problem | 3 | Device |
| 2017 | Invalid Sensing | 5 | Device |
| 2017 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 5 | Device |
| 2017 | Inappropriate or Unexpected Reset | 2 | Device |
| 2017 | Impedance Problem | 1 | Device |
| 2017 | High impedance | 1 | Device |
| 2017 | High Capture Threshold | 2 | Device |
| 2017 | Failure to Charge | 1 | Device |
| 2017 | Electrical /Electronic Property Problem | 2 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Device Alarm System | 1 | Device |
| 2017 | Delayed Charge Time | 4 | Device |
| 2017 | Communication or Transmission Problem | 3 | Device |
| 2017 | Charging Problem | 2 | Device |
| 2017 | Battery Problem: High Impedance | 2 | Device |
| 2017 | Battery Problem | 10 | Device |
| 2017 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Unable to Obtain Readings | 3 | Device |
| 2016 | Reset Problem | 2 | Device |
| 2016 | Premature Discharge of Battery | 12 | Device |
| 2016 | Pacing Problem | 2 | Device |
| 2016 | Over-Sensing | 5 | Device |
| 2016 | Missing Test Results | 2 | Device |
| 2016 | Misconnection | 1 | Device |
| 2016 | Migration or Expulsion of Device | 2 | Device |
| 2016 | Mechanical Problem | 7 | Device |
| 2016 | Low impedance | 1 | Device |
| 2016 | Invalid Sensing | 12 | Device |
| 2016 | Intermittent Capture | 1 | Device |
| 2016 | Incorrect Measurement | 1 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 12 | Device |
| 2016 | False Alarm | 1 | Device |
| 2016 | Failure to Interrogate | 1 | Device |
| 2016 | Failure to Convert Rhythm | 1 | Device |
| 2016 | Device Sensing Problem | 1 | Device |
| 2016 | Delayed Charge Time | 2 | Device |
| 2016 | Defibrillation/Stimulation Problem | 4 | Device |
| 2016 | Battery Problem | 4 | Device |
| 2016 | Appropriate Term/Code Not Available | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Premature Discharge of Battery | 2 | Device |
| 2015 | Invalid Sensing | 1 | Device |
| 2015 | Inappropriate or Unexpected Reset | 1 | Device |
| 2015 | Device Sensing Problem | 1 | Device |
| 2014 | Unable to Obtain Readings | 5 | Device |
| 2014 | Reset Problem | 1 | Device |
| 2014 | Protective Measures Problem | 1 | Device |
| 2014 | Premature Discharge of Battery | 27 | Device |
| 2014 | Pacing Problem | 2 | Device |
| 2014 | Over-Sensing | 2 | Device |
| 2014 | Nonstandard Device | 27 | Device |
| 2014 | Migration or Expulsion of Device | 1 | Device |
| 2014 | Mechanical Problem | 4 | Device |
| 2014 | Invalid Sensing | 5 | Device |
| 2014 | Incorrect Measurement | 1 | Device |
| 2014 | Inappropriate/Inadequate Shock/Stimulation | 5 | Device |
| 2014 | Inappropriate or Unexpected Reset | 3 | Device |
| 2014 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2014 | High impedance | 1 | Device |
| 2014 | Failure to Interrogate | 3 | Device |
| 2014 | Failure to Convert Rhythm | 2 | Device |
| 2014 | Device Alarm System | 1 | Device |
| 2014 | Defibrillation/Stimulation Problem | 1 | Device |
| 2014 | Communication or Transmission Problem | 1 | Device |
| 2014 | Battery Problem | 5 | Device |
| 2014 | Appropriate Term/Code Not Available | 2 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2013 | Unspecified Infection | 1 | Patient |
| 2013 | Unable to Obtain Readings | 1 | Device |
| 2013 | Premature Discharge of Battery | 8 | Device |
| 2013 | Over-Sensing | 1 | Device |
| 2013 | Nonstandard Device | 8 | Device |
| 2013 | Mechanical Problem | 1 | Device |
| 2013 | Invalid Sensing | 1 | Device |
| 2013 | Inappropriate/Inadequate Shock/Stimulation | 4 | Device |
| 2013 | Failure to Charge | 1 | Device |
| 2013 | Failure to Capture | 1 | Device |
| 2013 | Battery Problem | 2 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2012 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2011 | Nonstandard Device | 1 | Device |
| 2011 | Inappropriate/Inadequate Shock/Stimulation | 4 | Device |
| 2010 | Nonstandard Device | 1 | Device |
| 2010 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2010 | Device Expiration Issue | 1 | Device |
| 2009 | Nonstandard Device | 1 | Device |
| 2009 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |