Model Number V173 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problems
No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/21/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The device has not been returned at this time.If it is returned, analysis will be performed, and this report will be updated.
|
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reached elective replacement indicator (eri).The device then exhibited three alert codes and was found to be operating in safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Patient code 3191 is being used to capture the additional intervention performed.The device has not been returned at this time.If it is returned, analysis will be performed, and this report will be updated.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.External visual inspection of the device revealed signs of battery swelling.The device case was then opened to facilitate analysis of the internal components.The battery was separated from the other device electronics and the overall current draw of the circuitry was measured.The battery analysis determined that there was a short in the cell caused from the cathode tab coming in contact with the can due to a torn insulator tube.This internal short in the battery was determined to be the cause for the battery depleting faster than expected and for the observed reversion to safety mode.
|
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reached elective replacement indicator (eri).The device then exhibited three alert codes and was found to be operating in safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.
|
|
Search Alerts/Recalls
|