Model Number G126 |
Device Problems
Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 03/21/2023 |
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.
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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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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 the allegation against the device was not confirmed.The device was analyzed, passed all the baseline tests and exhibited normal device functions.This supplemental is being filed to capture the investigation results.If information is provided in the future, a supplemental report will be issued.
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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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This supplemental report was created to update h6: device codes: device not re-used.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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