Date of event is estimated.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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Related manufacturer reference number: 1627487-2023-04199.It was reported that the patient¿s therapy was affected due to high impedance.Reportedly, the patient rotated their ipg resulting in the fracture of the right extension.As such, surgical intervention took place on (b)(6) 2023 wherein the extension was explanted and replaced with a new extension addressing the issue.Additionally, the ipg was repositioned to its correct orientation.Reportedly, therapy was restored post op.
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