Model Number 1192 |
Device Problem
Break (1069)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 03/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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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.Manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 4 of 4.Reference mfr.Report# 1627487-2018-02874, reference mfr.Report#3006705815-2018-00602, reference mfr.Report# 1627487-2018-02876.It was reported (b)(6) during the scs trial, one of the lead was migrated as the anchor was broken.X-rays confirmed the issue.The patient underwent surgical intervention on (b)(6) 2018 wherein the lead was repositioned and the anchor was explanted and replaced.It is unknown which device is related to the issue.Therefore all the possible devices are being reported.Device information is unknown at this time.
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Event Description
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Device 4 of 4.Reference mfr.Report# 1627487-2018-02874, reference mfr.Report#3006705815-2018-00602 , reference mfr.Report# 1627487-2018-02876.
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Event Description
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Device 4 of 4.Reference mfr.Report# 1627487-2018-02874, reference mfr.Report#3006705815-2018-00602, reference mfr.Report# 1627487-2018-02876.
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Search Alerts/Recalls
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