During processing of this complaint, 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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Related manufacturer reference number:3006705815-2020-33370.It was reported that during a permanent implant procedure on (b)(6) 2020, the physician opted to use two percutaneous leads due to the space being too tight for paddle lead placement.The leads kept moving ventral as the physician attempted to decompress the area.The neuromonitoring readings were declining when the surgeon opted to remove the leads and abandon the procedure.Once the leads were removed, the neuromonitoring reading improved and the patient is reportedly doing fine following the procedure.
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