Model Number 3186 |
Device Problems
Therapy Delivered to Incorrect Body Area (1508); Impedance Problem (2950)
|
Patient Problems
Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
|
Event Type
Injury
|
Event Description
|
Device 1 of 2.Reference mfr.Report#: 1627487-2015-05220.It was reported, the patient has been unable to receive effective stimulation due to receiving stimulation in an unintended area.Reprogramming to provide resolution was unsuccessful.An impedance check revealed invalid impedance on the 3186 lead.Also, high impedance was found on the 3163 lead (for off-label use).X-rays were taken and showed lead migration pertaining to the 3163 lead.As a result, the patient may undergo surgical intervention.
|
|
Event Description
|
Device 1 of 2.Reference mfr.Report#: 1627487-2015-05220.Follow-up revealed the patient's leads were explanted and replaced.Surgical intervention resolved the patient's issue.
|
|
Manufacturer Narrative
|
(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.
|
|
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.
|
|
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
|
Device 1 of 2.Reference mfr.Report#: 1627487-2015-05220.
|
|
Search Alerts/Recalls
|