Model Number A219 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device was explanted and returned to boston scientific for analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Supplemental: upon receipt at our post market quality assurance laboratory, this s-icd 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 a compromised capacitor.This resulted in the observed premature battery depletion.It was determined that the capacitor was compromised due to the presence of excess hydrogen in the device case.Boston scientific issued a field safety notice regarding a subset of emblem devices that have a potential of exhibiting this behavior.This particular device is included in the emblem s-icd accelerated depletion advisory population.Initial: if information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device was explanted and returned to boston scientific for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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