Model Number 3186 |
Device Problem
Bent (1059)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 10/10/2016 |
Event Type
Injury
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Manufacturer Narrative
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(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.(b)(4).
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Event Description
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Device 1 of 2.Reference mfr report#1627487-2016-05679.The patient reported bending over during which time she felt a popping sensation in the lower back area.Subsequently, stimulation was lost.Reportedly, x-rays observed the lead was bent.In turn, the patient requested surgical intervention as the next course of action.
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Manufacturer Narrative
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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.
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Event Description
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Device 1 of 2.Reference mfr report#1627487-2016-05679.Follow-up identified surgical intervention was undertaken during which time the system was explanted.
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Search Alerts/Recalls
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