Model Number 3186 |
Device Problems
Malposition of Device (2616); Device Operates Differently Than Expected (2913)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 12/17/2014 |
Event Type
Injury
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Event Description
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Device 2 of 2.Reference mfr.Report# 1627487-2014-20020.
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Event Description
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Device 2 of 2.Reference mfr.Report# 1627487-2014-20022.
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Manufacturer Narrative
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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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Event Description
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Device 2 of 2.Reference mfr.Report# 1627487-2014-20020.
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Manufacturer Narrative
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Result - complaint was not confirmed for ¿ineffective stimulation.¿ as received, both the octrodes were complete and passed continuity testing and resistance measurement.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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