Model Number A219 |
Device Problems
Premature Discharge of Battery (1057); High impedance (1291); Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2023 |
Event Type
Injury
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Event Description
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It was reported that the battery of this subcutaneous implantable cardioverter defibrillator (s-icd) was suspected to be depleting prematurely as it displayed a battery alert and it was beeping.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The device remains in service and there is no evidence to suggest a device replacement procedure has been scheduled at this time.No adverse patient effects were reported.
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Event Description
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This supplemental report is being filed to provide additional information that the product has been explanted and replaced.The entire system was explanted and replaced.The electrode was replaced for high impedances and stimulation.The pulse generator was replaced due to premature battery depletion.There were no additional adverse patient effects.It was reported that the battery of this subcutaneous implantable cardioverter defibrillator (s-icd) was suspected to be depleting prematurely as it displayed a battery alert and it was beeping.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The device exhibited a high impedance.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 an advisory communication in august 2019 regarding a subset of emblem devices that has an elevated potential of exhibiting this behavior; the population of devices that may be impacted was expanded in december 2020.This particular device is included in the emblem s-icd accelerated depletion advisory population.
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Event Description
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This supplemental report is being filed to provide additional information regarding product analysis.This supplemental report is being filed to provide additional information that the product has been explanted and replaced.The entire system was explanted and replaced.The electrode was replaced for high impedances and stimulation.The pulse generator was replaced due to premature battery depletion.There were no additional adverse patient effects.It was reported that the battery of this subcutaneous implantable cardioverter defibrillator (s-icd) was suspected to be depleting prematurely as it displayed a battery alert and it was beeping.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The device exhibited a high impedance.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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