Model Number 3189 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Abscess (1690)
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Event Date 09/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with the investigation results will be provided in the final report.
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Event Description
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Device 2 of 2.Reference mfr.Report#: 1627487-2019-10993.This report is in reference to a (b)(6) patient.It was reported the patient was admitted to the hospital due to swelling and was later diagnosed with an abscess at their lead site.As a result, a debridement was performed and their leads were explanted.The patient was administered medication and their wound is still healing.
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Manufacturer Narrative
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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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Event Description
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Device 2 of 2.Reference mfr.Report#: 1627487-2019-10993.Follow-up revealed the patient's issue resolved via antibiotic medication.
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Search Alerts/Recalls
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