Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 12/18/2023 |
Event Type
Injury
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Event Description
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Related manufacturer reference number 3006705815-2024-00551, 3006705815-2024-00552, 1627487-2024-00371.It was reported an infection was present at the lead site which resulted in fluid buildup.Patient was prescribed oral antibiotics and is going to a wound clinic twice a week.Patient had system explanted to address the issue.
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Manufacturer Narrative
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Date of the event is estimated.
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Manufacturer Narrative
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A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Manufacturer Narrative
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It was reported that the infection has resolved and the wound is healing, an antibiotic medicine is being applied to the wounds.
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Search Alerts/Recalls
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