Model Number 3286 |
Device Problem
Therapy Delivered to Incorrect Body Area (1508)
|
Patient Problems
Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
|
Event Type
Injury
|
Event Description
|
Follow-up revealed the patient's lead was relocated on (b)(6) 2015.The patient received effective therapy and no abdominal stimulation during intraoperative testing.
|
|
Manufacturer Narrative
|
Sjm has limited information related to the patient¿s medical history and is unable to form an opinion as to the relevancy of the patient¿s history to the event reported.Sjm defers to the patient¿s physician regarding medical history.
|
|
Event Description
|
The patient has two leads from the same lot.It was reported the patient has not been receiving effective therapy due to getting stimulation in unintended area from her right lead.As a result, the patient will undergo surgical intervention.
|
|
Manufacturer Narrative
|
Udi (di): (b)(4).Sjm has limited information related to the patient¿s medical history and is unable to form an opinion as to the relevancy of the patient¿s history to the event reported.Sjm defers to the patient¿s physician regarding medical history.
|
|
Search Alerts/Recalls
|