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.
|
It was reported that during a perm implant procedure on (b)(6) 2020, the physician punctured the epidural space during entry resulting in a cerebrospinal fluid (csf) leak.The physician completed the procedure by entering at a different level.Post-operatively, the patient experienced a headache which resolved over time with prescribed medication.
|