Model Number 3664 |
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 01/29/2024 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.Additional components potentially involved in the event include: common device name: 50cm implant lead kit, slim tip, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 6607553.
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Event Description
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Related manufacturer reference number: 1627487-2024-07054.It was reported that the patient was experiencing pain at the ipg site and ineffective therapy.Surgical intervention may be pending 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 was received wherein the scs system was explanted to address the issue.
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Search Alerts/Recalls
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