Model Number A219 |
Device Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/17/2023 |
Event Type
Injury
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Event Description
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It was reported, that this subcutaneous implantable cardioverter defibrillator (s-icd) device, displayed battery depletion alert showing signs of premature battery depletion (pbd).There has been a decrease in battery longevity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device currently remains in service.No additional adverse patient effects were reported.
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Event Description
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It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) device displayed battery depletion alert showing signs of premature battery depletion (pbd).There has been a decrease in battery longevity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device currently remains in service.No additional 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 this subcutaneous implantable cardioverter defibrillator (s-icd) device displayed battery depletion alert showing signs of premature battery depletion (pbd).There has been a decrease in battery longevity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device currently remains in service.No additional 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 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.
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Search Alerts/Recalls
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