Model Number A209 |
Device Problems
No Audible Alarm (1019); Interrogation Problem (4017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2023 |
Event Type
Injury
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Event Description
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It was reported that, during an office follow-up, this device could not be interrogated.The application of a magnet did not yield tones.Technical services suspects the battery has reached end-of-life.The device has been implanted greater than five years.The device remains implanted.There were no adverse patient effects.
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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.There were no additional adverse patient effects.It was reported that, during an office follow-up, this device could not be interrogated.The application of a magnet did not yield tones.Technical services suspects the battery has reached end-of-life.The device has been implanted greater than five years.The device remains implanted.There were no adverse patient effects.
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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, during an office follow-up, this device could not be interrogated.The application of a magnet did not yield tones.Technical services suspects the battery has reached end-of-life.The device has been implanted greater than five years.The device remains implanted.There were no 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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Search Alerts/Recalls
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