Model Number D001 |
Device Problems
Delayed Charge Time (2586); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/10/2019 |
Event Type
Injury
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Event Description
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It was reported this implantable cardioverter defibrillator (icd) declared code 1007, capacitor charge time has exceeded the limit.Subsequently, the patient underwent surgical intervention to have device explanted and replaced.No adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
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Manufacturer Narrative
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A thorough evaluation of the device was performed upon receipt at our post market quality assurance laboratory.Visual inspection of the device noted no anomalies.Review of device memory indicated that a charge timeout alert (> 45 seconds) had been recorded.The device case was opened, and visual inspection noted that one of the two high voltage (hv) capacitors was slightly swollen.The hv capacitor was analyzed, and it was concluded that the hv capacitor experienced internal arcing caused by a low resistance pathway between anode and cathode plates within the capacitor.This capacitor issue impacted the device's ability to provide shock therapy because the hv capacitors could not be fully charged, but brady pacing, telemetry, and other device functionality remained available.
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Event Description
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It was reported this implantable cardioverter defibrillator (icd) declared code 1007, capacitor charge time has exceeded the limit.Subsequently, the patient underwent surgical intervention to have device explanted and replaced.No adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
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Search Alerts/Recalls
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