Model Number G124 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Unspecified Infection (1930)
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Event Date 12/27/2023 |
Event Type
Injury
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Manufacturer Narrative
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This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited infection.Also, patient fell and landed on device area and had hematoma and got infected, a revision was performed and the crt-d along with the right ventricular (rv) lead, right atrial (ra) lead and bundle of his lead were explanted.No additional adverse patient effects were reported.This crt-d will be returned for analysis.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited infection.Also, patient fell and landed on device area and had hematoma and got infected, a revision was performed and the crt-d along with the right ventricular (rv) lead, right atrial (ra) lead and bundle of his lead were explanted.No additional adverse patient effects were reported.This crt-d will be returned for analysis.
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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.Detailed analysis did not confirm the allegation.The device was successfully interrogated and completed a memory dump.Visual inspection found no irregularities that would have been present when the customer received /utilized the device, and the header was firmly attached.The longevity calculation for this device passed or was not applicable.Moreover, known inherent risk was selected based on the field report of infection.Infection is a known medical risk when the skin barrier is breached.Analysis of the returned product is not able to provide relevant information for infection-related allegations.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
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Search Alerts/Recalls
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