Model Number 3788 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problems
Fall (1848); Inadequate Pain Relief (2388)
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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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Device 1 of 2.Reference mfr report: 1627487-2016-05511.The patient has two leads implanted with the same lot number.It was reported the patient only receives stimulation when she presses on the ipg site.Surgical intervention may be pending to 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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Device 1 of 2.Reference mfr report: 1627487-2016-05511.Follow up information identified the patient's ipg was replaced with a new one which resolved the issue.
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Search Alerts/Recalls
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