Device 4 of 4.Reference mfr report: 1627487-2019-01067, 1627487-2019-02160, 1627487-2019-02161.It was reported that the patient was experiencing high impedances and inefficient stimulation as a result of the extensions pulling out of the ipg header.The patient underwent surgery to explant and replace the extensions, which resolved the issue.
|
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.During processing of this complaint, attempts were made to obtain patient weight, but it could not be obtained.
|