Model Number 3788 |
Device Problems
Nonstandard Device (1420); Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/15/2016 |
Event Type
Injury
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Manufacturer Narrative
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Recall: 1627487-12192011-003-r.This ipg serial number was included in field advisories.(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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The patient received two scs ipgs (left side and right side).This report is for left side ipg.It was reported the patient's ((b)(6)) ipg intermittently turns off by itself.Consequently, surgical intervention will be taken at a later date 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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Additional information received identified the ipg was explanted and replaced which resolved the issue.
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Search Alerts/Recalls
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