Model Number L311 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2022 |
Event Type
Injury
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Event Description
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It was reported that there were concerns of premature battery depletion (pbd) with this subcutaneous implantable cardioverter defibrillator device.Battery longevity has also decreased through the course of 4 years.Data analysis showed the battery appeared to be depleting more quickly than expected, and a boston scientific technical services (ts) consultant recommended device replacement.Device remains in service.No adverse patient effects were reported.
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Event Description
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It was reported that there were concerns of premature battery depletion (pbd) with this subcutaneous implantable cardioverter defibrillator device.Battery longevity has also decreased through the course of 4 years.Data analysis showed the battery appeared to be depleting more quickly than expected, and a boston scientific technical services (ts) consultant recommended device replacement.Device remains in service.No adverse patient effects were reported.Subsequently, additional information was received indicating device was explanted and replaced.No additional adverse patient effects were reported.
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Event Description
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It was reported that there were concerns of premature battery depletion (pbd) with this subcutaneous implantable cardioverter defibrillator device.Battery longevity has also decreased through the course of 4 years.Data analysis showed the battery appeared to be depleting more quickly than expected, and a boston scientific technical services (ts) consultant recommended device replacement.Device remains in service.No adverse patient effects were reported.Subsequently, additional information was received indicating device was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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