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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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.Medical devices: the therapy date for the following device is unknown: model: 3772; scs ipg.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: 1627487-2017-08702.It was reported ((b)(6)) the patient experienced ineffective stimulation due to lead migration.As such, surgical intervention was undertaken during which the leads were explanted and replaced with a paddle lead.Effective stimulation was restored following the procedure.
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Event Description
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Device 1 of 2.Reference mfr.Report: 1627487-2017-08702.
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Search Alerts/Recalls
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