Model Number L231 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885); Human-Device Interface Problem (2949)
|
Patient Problem
Anxiety (2328)
|
Event Date 12/17/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional information was requested.The investigation will be updated should further information be provided.
|
|
Event Description
|
It was reported that the battery of this implantable device was suspected to be depleting prematurely.Remaining longevity decreased five and a half years between one year follow-ups, power consumption of 129%.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.Patient experienced anxiety as a result and is being remotely monitored, no medication needed.Physician very concerned of the battery behavior of proponent devices.This device remains in service.No additional adverse patient effects were reported.
|
|
Event Description
|
It was reported that the battery of this implantable device was suspected to be depleting prematurely.Remaining longevity decreased five and a half years between one year follow-ups, power consumption of 129%.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.Patient experienced anxiety as a result and is being remotely monitored, no medication needed.Physician very concerned of the battery behavior of proponent devices.This device was replaced and is expected to be returned for analysis.No additional adverse patient effects were reported.The complaint device has not been returned by the customer yet; therefore, no product analysis could be performed.
|
|
Manufacturer Narrative
|
Additional information was requested.The investigation will be updated should further information be provided.If information is provided in the future, a supplemental report will be issued.
|
|
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 in (b)(6) 2018, which was expanded in (b)(6) 2021, regarding a subset of devices in the accolade pacemaker family that has an elevated potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.Additional information was requested.The investigation will be updated should further information be provided.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the battery of this implantable device was suspected to be depleting prematurely during a routine follow up.The estimated longevity decreased five and a half years within one year period.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.Patient experienced anxiety as a result and is being remotely monitored, no medication was required.The physician expressed concerns regarding the battery behavior of proponent devices.This device was replaced and returned for analysis.No additional adverse patient effects were reported.
|
|
Search Alerts/Recalls
|