PULSE GENERATOR, PERMANENT, IMPLANTABLE
This device is manufactured by MDT PUERTO RICO OPERATIONS CO MED REL, MDT SOFAMOR DANEK PUERTO RICO MFG, MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC MED REL MEDTRONIC PUERTO RICO and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Ventricular Fibrillation | 1 | Patient |
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | False Alarm | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Fall | 1 | Patient |
| 2023 | Device Overstimulation of Tissue | 1 | Patient |
| 2023 | Premature Discharge of Battery | 2 | Device |
| 2023 | Pocket Stimulation | 1 | Device |
| 2023 | Pacing Problem | 4 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Failure to Interrogate | 1 | Device |
| 2023 | Component Missing | 1 | Device |
| 2023 | Communication or Transmission Problem | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Under-Sensing | 1 | Device |
| 2022 | Premature Discharge of Battery | 4 | Device |
| 2022 | Pacing Problem | 2 | Device |
| 2022 | Misconnection | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | Failure to Capture | 3 | Device |
| 2019 | Under-Sensing | 1 | Device |
| 2019 | Premature Discharge of Battery | 9 | Device |
| 2019 | Pacing Problem | 2 | Device |
| 2019 | Mechanical Problem | 2 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | High Capture Threshold | 1 | Device |
| 2019 | Failure to Interrogate | 1 | Device |
| 2019 | Failure to Capture | 3 | Device |
| 2019 | Device-Device Incompatibility | 1 | Device |
| 2019 | Device Sensing Problem | 2 | Device |
| 2019 | Communication or Transmission Problem | 2 | Device |
| 2019 | Battery Problem: High Impedance | 1 | Device |
| 2019 | Battery Problem | 4 | Device |
| 2019 | Appropriate Term/Code Not Available | 5 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2018 | Under-Sensing | 2 | Device |
| 2018 | Unable to Obtain Readings | 3 | Device |
| 2018 | Signal Artifact/Noise | 2 | Device |
| 2018 | Reset Problem | 1 | Device |
| 2018 | Programming Issue | 1 | Device |
| 2018 | Premature Discharge of Battery | 22 | Device |
| 2018 | Pacing Problem | 8 | Device |
| 2018 | Over-Sensing | 4 | Device |
| 2018 | Output above Specifications | 1 | Device |
| 2018 | Output Problem | 3 | Device |
| 2018 | Mechanical Problem | 4 | Device |
| 2018 | Material Erosion | 1 | Device |
| 2018 | Invalid Sensing | 1 | Device |
| 2018 | Intermittent Capture | 1 | Device |
| 2018 | Insufficient Information | 1 | Device |
| 2018 | Incorrect Measurement | 4 | Device |
| 2018 | Inappropriate or Unexpected Reset | 1 | Device |
| 2018 | Impedance Problem | 1 | Device |
| 2018 | High impedance | 1 | Device |
| 2018 | Failure to Interrogate | 5 | Device |
| 2018 | Failure to Capture | 4 | Device |
| 2018 | Electromagnetic Interference | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 2 | Device |
| 2018 | Communication or Transmission Problem | 2 | Device |
| 2018 | Capturing Problem | 2 | Device |
| 2018 | Battery Problem | 3 | Device |
| 2018 | Appropriate Term/Code Not Available | 5 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2017 | Unspecified Infection | 1 | Patient |
| 2017 | Insufficient Information | 1 | Patient |
| 2017 | Unstable Capture Threshold | 1 | Device |
| 2017 | Under-Sensing | 2 | Device |
| 2017 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2017 | Signal Artifact/Noise | 1 | Device |
| 2017 | Reset Problem | 1 | Device |
| 2017 | Premature Discharge of Battery | 21 | Device |
| 2017 | Pacing Problem | 7 | Device |
| 2017 | Over-Sensing | 2 | Device |
| 2017 | Output above Specifications | 1 | Device |
| 2017 | Misconnection | 1 | Device |
| 2017 | Migration or Expulsion of Device | 1 | Device |
| 2017 | Mechanical Problem | 9 | Device |
| 2017 | Loose or Intermittent Connection | 3 | Device |
| 2017 | Invalid Sensing | 1 | Device |
| 2017 | Incorrect Measurement | 1 | Device |
| 2017 | Inappropriate or Unexpected Reset | 2 | Device |
| 2017 | High impedance | 2 | Device |
| 2017 | High Capture Threshold | 1 | Device |
| 2017 | Failure to Interrogate | 5 | Device |
| 2017 | Failure to Capture | 4 | Device |
| 2017 | Electromagnetic Interference | 1 | Device |
| 2017 | Electrical Overstress | 1 | Device |
| 2017 | Device Sensing Problem | 2 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Device Expiration Issue | 1 | Device |
| 2017 | Decreased Sensitivity | 1 | Device |
| 2017 | Communication or Transmission Problem | 1 | Device |
| 2017 | Capturing Problem | 1 | Device |
| 2017 | Battery Problem: High Impedance | 1 | Device |
| 2017 | Battery Problem | 6 | Device |
| 2017 | Appropriate Term/Code Not Available | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2016 | Unstable Capture Threshold | 1 | Device |
| 2016 | Under-Sensing | 1 | Device |
| 2016 | Unable to Obtain Readings | 2 | Device |
| 2016 | Signal Artifact/Noise | 1 | Device |
| 2016 | Premature Discharge of Battery | 10 | Device |
| 2016 | Pacing Problem | 9 | Device |
| 2016 | Over-Sensing | 3 | Device |
| 2016 | Output above Specifications | 1 | Device |
| 2016 | Misconnection | 2 | Device |
| 2016 | Migration or Expulsion of Device | 2 | Device |
| 2016 | Mechanical Problem | 3 | Device |
| 2016 | Loose or Intermittent Connection | 1 | Device |
| 2016 | Intermittent Capture | 1 | Device |
| 2016 | Incorrect Measurement | 1 | Device |
| 2016 | High Capture Threshold | 1 | Device |
| 2016 | Failure to Interrogate | 4 | Device |
| 2016 | Failure to Capture | 2 | Device |
| 2016 | Device-Device Incompatibility | 1 | Device |
| 2016 | Capturing Problem | 1 | Device |
| 2016 | Battery Problem | 3 | Device |
| 2016 | Appropriate Term/Code Not Available | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2015 | Premature Discharge of Battery | 2 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2014 | Insufficient Information | 2 | Patient |
| 2014 | Under-Sensing | 1 | Device |
| 2014 | Premature Discharge of Battery | 9 | Device |
| 2014 | Pacing Problem | 8 | Device |
| 2014 | Over-Sensing | 2 | Device |
| 2014 | Migration or Expulsion of Device | 1 | Device |
| 2014 | Mechanical Problem | 6 | Device |
| 2014 | Material Integrity Problem | 1 | Device |
| 2014 | Loose or Intermittent Connection | 1 | Device |
| 2014 | Insufficient Information | 1 | Device |
| 2014 | Incorrect Measurement | 2 | Device |
| 2014 | Inappropriate or Unexpected Reset | 1 | Device |
| 2014 | Impedance Problem | 1 | Device |
| 2014 | Failure to Interrogate | 3 | Device |
| 2014 | Failure to Charge | 1 | Device |
| 2014 | Communication or Transmission Problem | 1 | Device |
| 2014 | Battery Problem: High Impedance | 1 | Device |
| 2014 | Battery Problem | 6 | Device |
| 2014 | Appropriate Term/Code Not Available | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2013 | Pain | 1 | Patient |
| 2013 | Implant Pain | 1 | Patient |
| 2013 | Premature Discharge of Battery | 3 | Device |
| 2013 | Over-Sensing | 1 | Device |
| 2013 | Mechanical Problem | 1 | Device |
| 2013 | Insufficient Information | 3 | Device |
| 2013 | Incorrect Measurement | 1 | Device |
| 2013 | Device Expiration Issue | 1 | Device |
| 2013 | Battery Problem | 1 | Device |
| 2013 | Appropriate Term/Code Not Available | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2012 | Appropriate Term/Code Not Available | 1 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2010 | Premature Discharge of Battery | 1 | Device |
| 2010 | Pacing Problem | 1 | Device |
| 2009 | Adverse Event Without Identified Device or Use Problem | 1 | Device |