Model Number G148 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Date 12/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.(b)(4).
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection.There were no additional adverse patient effects reported.The crt-d was explanted.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that this explanted product was returned but no analysis was performed as reported allegations of infection were known inherent risk of device.This supplemental is being filed to capture the return date and investigation results.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection.There were no additional adverse patient effects reported.The crt-d was explanted.
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Search Alerts/Recalls
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