Model Number 3788 |
Device Problems
Device Stops Intermittently (1599); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Discomfort (2330)
|
Event Date 06/10/2016 |
Event Type
Injury
|
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.
|
|
Event Description
|
It was reported the patient's scs stimulation would turn off without prompting after one or two hours.The lead impedance was all normal and no change was observed in lead impedance when the stimulation went off.The patient's scs system was reprogrammed with a cycling mode but the patient complained the stimulation would become weakened after approximately five minutes.Additional reprogramming to a short cycle mode was attempted, however the patient complained it was too short as the patient preferred continuous mode which the patient complained it was uncomfortable.Follow-up identified the patient's physician replaced the scs ipg with a new one.
|
|
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.
|
|
Search Alerts/Recalls
|