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Model Number MN10450-50A |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this incident, attempts were made to obtain complete patient information.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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It was reported that the patient presented with high impedances on their s1 drg lead.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein the s1 drg lead was explanted and replaced to address the issue.It was also reported that the left l4 drg lead was accidentally hit, and it was explanted and replaced, during the same surgical procedure, to address the issue.Effective therapy was restored post-op.
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Search Alerts/Recalls
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