BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G447 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Fluid Discharge (2686)
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Event Date 08/23/2023 |
Event Type
Injury
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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.Reportedly, the patient presented to the hospital with fever, drainage, and redness at the pocket site.There were no additional adverse patient effects reported.This crt-d was explanted.
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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.Reportedly, the patient presented to the hospital with fever, drainage, and redness at the pocket site.There were no additional adverse patient effects reported.This 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 this device was not confirmed.This device was analyzed, passed all the baseline tests and exhibited normal device functions.This supplemental is being filed to capture d9: returned to manufacturer date and investigation results.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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