Model Number 3166 |
Device Problem
High impedance (1291)
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Patient Problems
Fall (1848); Inadequate Pain Relief (2388)
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Event Date 07/25/2018 |
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 4.Reference mfr.Report: 1627487-2018-08139.Reference mfr.Report: 1627487-2018-08141.Reference mfr.Report: 1627487-2018-08142.It was reported during programming after the patient suffered a fall, one of the patient¿s leads displayed high impedances.It was discovered 1 of 4 leads were not working.Reprogramming partially restored therapy.As a result, the patient is awaiting surgical intervention.
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Event Description
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Device 2 of 4; reference mfr.Report: 1627487-2018-08139, reference mfr.Report: 1627487-2018-08141, reference mfr.Report: 1627487-2018-08142.Follow-up information provided the patient had 4 leads explanted due to high impedances and replaced with 2 new leads.Effective stimulation was restored.
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Search Alerts/Recalls
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