Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Scar Tissue (2060); Inadequate Pain Relief (2388)
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Event Type
Injury
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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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Event Description
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Device 2 of 2.Reference mfr.Report#1627487-2017-00425.It was reported the patient underwent a surgical intervention on (b)(6) 2017 for better lead placement.Reportedly, the physician was unable to advance the leads due to scar tissue.As a result, both leads were removed and the case abandoned.The ipg remains implanted.
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Manufacturer Narrative
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Corrected device 2 of 2 mfr.Report# due to duplicated report number previously submitted on device 1.
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Event Description
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Device 2 of 2.Reference mfr.#3006705815-2017-00482.
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Event Description
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Device 2 of 2.Reference mfr.# 3006705815-2017-00482.Follow-up identified an additional surgery took place on (b)(6) 2017.Reportedly, the physician attempted to implant a paddle lead to no avail.The case was abandoned.
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Search Alerts/Recalls
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