Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Implant Pain (4561)
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Event Date 09/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer reference number: 1627487-2021-17630.It was reported that the patient experienced discomfort at the anchor site.Additionally, patient¿s lead has high impedances.Reportedly, patient has effective therapy of 50%.As such, surgical intervention may take place at a later date to address the issue.
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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 indicates that surgical intervention took on (b)(6) 2021 wherein the lead was explanted and replaced with a new lead.Additionally, the anchor was explanted to address the issues.Reportedly, therapy was confirmed post operatively.
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Search Alerts/Recalls
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