Model Number A219 |
Device Problems
No Audible Alarm (1019); Migration (4003); Interrogation Problem (4017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2023 |
Event Type
Injury
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Event Description
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It was reported that this device could not be interrogated.An attempt to do a magnet reset was unsuccessful.Also, the device appears to have migrated from the normal location.An invasive procedure was done and the device was explanted and replaced.There were no additional adverse patient effects.
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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.It was reported that this device could not be interrogated.An attempt to do a magnet reset was unsuccessful.Also, the device appears to have migrated from the normal location.An invasive procedure was done and the device was explanted and replaced.There were no additional adverse patient effects.
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Search Alerts/Recalls
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