Model Number 3788 |
Device Problem
No Device Output (1435)
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Patient Problem
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.
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Event Description
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It was reported the patient's charger was unable to establish communication with the ipg (event date unknown).Sjm representative confirmed the ipg is inoperable.Surgical intervention will be taken at a later date to address the issue.
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Event Description
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Additional information received identified the ipg was explanted and replaced with another model which resolved the issue.
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Manufacturer Narrative
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Corrected data: in supplement 001 "date received by manufacturer" was unintendedly typed incorrect.It should read aug 16, 2017 instead of aug 16, 2016.Explant date was unintendedly typed incorrect.It should read (b)(6) 2017 instead of (b)(6) 2016.This report consist of corrected data.
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Search Alerts/Recalls
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