Model Number G125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pocket Erosion (2013)
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Event Date 03/28/2024 |
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 system revision due to pocket erosion and infection.No additional adverse patient effects were 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 system revision due to pocket erosion and infection.No additional adverse patient effects were 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 indicated 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 report is being filed to correct the d9: device avail for eval; d9: device return date; g2: report source; h2: follow-up type; and h3: device eval by manufacturer.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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