Related manufacturer report number: 1627487-2024-07544.It was reported that the patient experienced pain on the left side.The physician reported that the left t12 is causing nerve pain.Manufacturer representative met with patient to reprogram, check impedances, and also turned off the stimulator.No impedances were found on the lead.However, the patient still reported to be experiencing pain on the left side. the physician and patient discussed to remove the left side and keep everything on the right.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein the left t12 and the left l1 lead were both cut and explanted to address the issue.
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Correction: section d6b-the date of explant should have not been submitted with the initial report because during removal, the leads were cut, and the distal end remains implanted and connected to the ipg [related manufacturer report number: 1627487-2024-07788, 1627487-2024-07789].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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