Model Number D153 |
Device Problems
Telemetry Discrepancy (1629); Interrogation Problem (4017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2022 |
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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It was reported that this implantable cardioverter defibrillator (icd) could not be interrogated despite trying several different programmers and wands.The patient reported their remote home monitoring system stopped working in (b)(6) 2022 which at the time the device had 9.5 years of battery life remaining.A magnet was applied to the device with no response.The device was explanted and replaced.Besides surgical intervention, there were no additional adverse patient impact.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, this device has no telemetry.The device case was opened.The battery voltage was measured but had no output.The battery was removed and sent for detailed analysis.In detailed battery analysis the battery was opened, and high-powered visual inspection confirmed that there was an extra piece of cathode material which caused the battery short.The cathode is the negative electrode where electricity flows out.This extra material and subsequent battery short are what caused the field allegations.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) could not be interrogated despite trying several different programmers and wands.The patient reported their remote home monitoring system stopped working in october 2022 which at the time the device had 9.5 years of battery life remaining.A magnet was applied to the device with no response.The device was explanted and replaced.Besides surgical intervention, there were no additional adverse patient impact.
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Search Alerts/Recalls
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