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.
|
Related manufacturer report number: 1627487-2021-00203.It was reported the patient was experiencing shocking in their back and down both legs.X-rays revealed one of the patient's lead had migrated.As a result, the patient underwent surgical intervention during which the system was explanted with no complications.It is unknown which lead had migrated, so both are being reported.
|