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: 1627487-2022-00806.Related manufacturer reference number: 1627487-2022-00807.It was reported that, during a drg revision (related manufacturer reference number: 1627487-2022-00248), the physician was not able to place the replacement l1 lead due to patient anatomy.As a result, the physician decided to use one of the patient's explanted leads to plug the port in the ipg; the lead was cut after insertion into the port.Following the procedure, the patient returned to the physician's office to receive a blood patch, as it was discovered that the patient suffered a dural leak during the procedure and the patient was experiencing a headache.The patient currently has effective therapy and the headache has resolved.Note: it is unknown which lead was used in the ipg port, so both are being reported on.
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