Model Number L331 |
Device Problem
Premature Discharge of Battery (1057)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/15/2022 |
Event Type
Injury
|
Event Description
|
It was reported that there were concerns the pacemaker was experiencing premature battery depletion (pbd).Boston scientific technical services (ts) confirmed via a data analysis that the device was prematurely depleting and recommended the device be replaced within 90 days.The device remains in use.No adverse patient effects were reported.
|
|
Event Description
|
It was reported that there were concerns the pacemaker was experiencing premature battery depletion (pbd).Boston scientific technical services (ts) confirmed via a data analysis that the device was prematurely depleting and recommended the device be replaced within 90 days.The device remains in use.No adverse patient effects were reported.Additional information received indicates this device explanted and replaced.No additional adverse patient effects were reported.
|
|
Event Description
|
It was reported that there were concerns the pacemaker was experiencing premature battery depletion (pbd).Boston scientific technical services (ts) confirmed via a data analysis that the device was prematurely depleting and recommended the device be replaced within 90 days.The device remains in use.No adverse patient effects were reported.Additional information received indicates this device explanted and replaced.No additional adverse patient effects were reported.The device was returned for analysis.
|
|
Manufacturer Narrative
|
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.Boston scientific issued a field safety notice regarding a subset of devices in the accolade pacemaker family that have a potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.
|
|
Search Alerts/Recalls
|