Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Burning Sensation (2146); Discharge (2225)
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Event Date 08/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The results/ method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Device 4 of 4.Related manufacturer reference number: 3006705815-2020-31225, related manufacturer reference number: 3006705815-2020-31226, related manufacturer reference number: 1627487-2020-31061.It was reported the patient experienced burning sensation and drainage at the lead incision site, along with a low-grade fever.A ct scan was normal.To address the issue, the physician opted to explant the patient¿s system.
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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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Additional information received indicated that the patient underwent surgical intervention on (b)(6) 2020 wherein the ipg was explanted and replaced.Reportedly, effective therapy was established.
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Search Alerts/Recalls
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