Model Number 3186 |
Device Problem
Therapy Delivered to Incorrect Body Area (1508)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 07/08/2015 |
Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr report#1627487-2015-08442.It was reported reprogramming did not provide effective stimulation to the desired areas.In addition, unintended therapy was delivered to the patient's side or stomach.X-rays were ordered and results revealed the leads have migrated.Surgical intervention may be undertaken as the next course of action.
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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.Udi(di): (b)(4).
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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#1627487-2015-08442.Additional information received identified the patient underwent surgical intervention on (b)(6) 2015 during which the scs leads were repositioned (with new anchors).Effective stimulation was restored and unintended stimulation was resolved with the surgical intervention.
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Search Alerts/Recalls
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