Model Number U228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Sepsis (2067)
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Event Date 12/21/2021 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was part of a system revision due to infection with sepsis.There were no additional adverse patient effects reported.The crt-p 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.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.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.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.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was part of a system revision due to infection with sepsis.There were no additional adverse patient effects reported.The crt-p was explanted.
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Search Alerts/Recalls
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