Model Number 3186 |
Device Problem
Impedance Problem (2950)
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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 2 of 2.Reference mfr.Report: 1627487-2018-06729.It was reported the patient received intermittent stimulation that was posture-related.Reprogramming was attempted; however the issue persisted.Diagnostics indicated higher impedance values.Surgical intervention is planned to address the issue.
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Event Description
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Device 2 of 2 : reference mfr.Report: 1627487-2018-06729.Follow-up identified the patient's leads had migrated.Surgical intervention was undertaken on (b)(6) 2018 during which both leads were explanted and replaced with a paddle lead.Stimulation was restored following the procedure.
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Search Alerts/Recalls
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