Model Number 3228 |
Device Problem
Cut In Material (2454)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 03/24/2016 |
Event Type
Injury
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Manufacturer Narrative
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(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.(b)(4).
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Event Description
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It was reported the patient experienced loss of therapy as the physician unintendedly cut the scs lead during the ipg replacement procedure on (b)(6) 2016 (reference mfr report # 1627487-2016- 01915).The cut lead was left implanted at the time.Surgical intervention will be taken at a later date address the issue.
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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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Additional information received identified the patient underwent surgical intervention on (b)(6) 2016 were in the cut lead was replaced with another one which resolved the issue.Reportedly, therapy was resumed postoperatively.
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Manufacturer Narrative
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(date of explant) was unintendedly left blank in previous report # 002.This report consists of missing information.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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