Model Number G447 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067); No Code Available (3191)
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Event Date 06/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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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.Additional information indicates that the patient was hospitalized due to methicillin-resistant staphylococcus aureus (mrsa) sepsis and was rehospitalized due to mrsa bacteremia and infectious disease.Hence, system extraction was opted.There were no additional adverse patient effects reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.Patient code 3191 captures the reportable event of surgery.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 product return date and a pertinent additional information was received.
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Search Alerts/Recalls
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