Model Number 429888 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
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Event Date 11/10/2018 |
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 the patient experienced an infection approximately one month post-cardiac resynchronization therapy defibrillator (crt-d) system implant with an absorbable envelope.The system was removed and a temporary system was utilized for approximately one week until a new system could be implanted.No further patient complications have been reported as a result of this event.
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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 later reported that no infection was found via culture tests and the physician thought it may have been an allergic reaction.
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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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The patient also required antibiotic treatment.
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Search Alerts/Recalls
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