Model Number 3186 |
Device Problem
No Device Output (1435)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 04/20/2017 |
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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Patient has 2 leads (same lot) implanted as part of her scs system.Device 2 of 2.Reference mfr.Report#: 1627487-2017-02606.It was reported the patient scs was not working.In turn, the patient may undergo surgical intervention to address the issue.No further information is known at this time.
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Event Description
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Device 2 of 2, reference mfr.Report#: 1627487-2017-02606.Follow-up information revealed the patient stated she was receiving effective pain relief from the system.The patient underwent surgical intervention wherein the entire scs system was explanted.
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Search Alerts/Recalls
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