Model Number T175 |
Device Problems
No Audible Alarm (1019); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/20/2009 |
Event Type
Injury
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Manufacturer Narrative
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The product has been received for analysis.This report will be updated upon completion of analysis.
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Event Description
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Boston scientific received information that this implantable cardioverter defibrillator (icd) exhibited a long charge time of 18.4 seconds with a monitoring voltage of 2.61 seconds, however, the charge time was within the extended charge time limit and elective replacement indicator (eri) had not been reached.A health care professional (hcp) contacted boston scientific technical services (ts) and inquired about eri triggers.Subsequent information was received that the icd was unable to be interrogated with a programmer and did not emit tones with magnet placement approximately 8 years later.It was noted that the patient had been lost to follow up for several years.An invasive procedure was performed.The device was explanted and replaced.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, a thorough evaluation of the device was performed.The device was returned with no telemetry function.An external power supply was connected to the device and noted that the no telemetry function was due to the battery being depleted.Laboratory analysis confirmed that charge times prior to depletion were within appropriate limits.Laboratory analysis concluded that the clinical observations were a result of the battery being depleted from the device being implanted beyond the life expectancy.
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Search Alerts/Recalls
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