Model Number A209 |
Device Problems
Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/30/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was on advisory and at elective replacement indicator (eri).This s-icd was explanted and replaced.The new device 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 on advisory and at elective replacement indicator (eri).This s-icd was explanted and replaced.The new device remains in service.No 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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Event Description
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It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was on advisory and at elective replacement indicator (eri).This s-icd was explanted and replaced.The new device remains in service.No 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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