Model Number 3156 |
Device Problem
Therapy Delivered to Incorrect Body Area (1508)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr report #1627487-2015-12314.Note: the patient received two leads from the same lot number (device 1).It was reported, the patient lost stimulation following a car accident.Reprogramming was unable to provide effective therapy.Images were taken and surgical intervention has been scheduled.
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Event Description
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Device 1 of 2.Reference mfr report #1627487-2015-12314
it was reported the patient's leads had migrated due to an automobile accident.The leads were repositioned and anchored.The patient reported she has effective therapy.
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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.
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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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Search Alerts/Recalls
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