Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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The manufacturer 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.The manufacturer 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: 1627487-2017-08698.It was reported (b)(6) the patient experienced unintended stimulation (outside of his pain area) a day post-implant.Reprogramming was attempted to no avail.Surgical intervention will be undertaken to address the issue.
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Event Description
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Device 1 of 2, reference mfr.Report: 1627487-2017-08698.Follow up revealed that the patient's recent x-ray shows the leads have migrated half a vertebral body upwards from t7-t8 to 1/2t6-1/2t8.
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Event Description
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Device 1 of 2.Reference mfr.Report: 1627487-2017-08698.Follow up information received identified the patient underwent a lead replacement surgery.Postoperatively, the patient reported receiving 100% coverage of his pain area.
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Search Alerts/Recalls
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