Model Number U228 |
Device Problems
Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)
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Event Date 12/22/2020 |
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.(b)(4).
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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.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-p was explanted.
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Manufacturer Narrative
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Patient code 3191 captures the reportable event of surgery and the additional intervention performed by the use of intravenous antibiotics.Upon receipt at our post market quality assurance laboratory additional information from product investigation indicates that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.There was no indication the device manufacturing process contributed to the reported complaint.Infection is a known medical risk when the skin barrier is breached.Analysis of the returned product was not able to provide relevant information for infection-related allegations.
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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.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-p was explanted.
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Search Alerts/Recalls
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