Model Number 3186 |
Device Problems
Break (1069); Kinked (1339); Impedance Problem (2950)
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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 2 of 2.Reference mfr.Report#: 1627487-2015-23210.
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Event Description
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Device 2 of 2 reference mfr.Report#: 1627487-2015-23210.
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Manufacturer Narrative
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Results: the complaint for ¿invalid impedance¿ was confirmed.As received, the returned octrode lead had kink with multiple internal wires broken.When aligned with a swift lock anchor, the breakage corresponds to a distal end fracture.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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Udi (di): (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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Search Alerts/Recalls
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