Model Number A219 |
Device Problems
Premature Discharge of Battery (1057); Telemetry Discrepancy (1629)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2023 |
Event Type
Injury
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Event Description
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It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was unable to be interrogated as the device was suspected to have been depleting prematurely.This device was scheduled to be explanted at a future date, however; currently remains in service.No 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) was unable to be interrogated as the device was suspected to have been depleting prematurely.This device was then explanted and replaced.This s-icd was subsequently returned for analysis.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.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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Event Description
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It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was unable to be interrogated as the device was suspected to have been depleting prematurely.This device was then explanted and replaced.This s-icd was subsequently returned for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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