Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 03/06/2018 |
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 3 of 3: reference mfr.Report#: 1627487-2018-06894, reference mfr.Report#: 1627487-2018-06895.This report is in reference to an (b)(6) patient.It was reported the patient had been receiving stimulation in unintended areas.Reprogramming was attempted but was being received at the pocket/ipg site.In turn, the doctor decided to explant the patient's scs system.
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Event Description
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Device 3 of 3 : reference mfr.Report#: 1627487-2018-06894 , reference mfr.Report#: 1627487-2018-06895.
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Search Alerts/Recalls
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