Model Number 3788 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/25/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This ipg serial number was included in a field advisory.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.Udi(di): (b)(4).
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Event Description
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It was reported the patient's ipg was inoperable and could not communicate with multiple external devices.Subsequently, surgical intervention was undertaken to explant and replace the ipg.Effective stimulation was restored following the procedure.
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Manufacturer Narrative
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Corrected data: has been updated with the correct explant date.
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Search Alerts/Recalls
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