Model Number 3788 |
Device Problems
Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
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Patient Problems
Pain (1994); Inadequate Pain Relief (2388)
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Event Date 07/02/2015 |
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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It was reported, the patient's ipg was unable to communicate with multiple programmers (programmer prompt comm error 2501) and had intermittent communication with the charger.A sjm representative confirmed the issue.It was also reported, the patient experienced pain at the ipg site.The ipg appeared to be shallow.The physician believed the pain at the ipg site is coincidental with existing si joint pain.Additionally, the patient underwent surgical intervention where the ipg was explanted and replaced which resolved the issue.
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Manufacturer Narrative
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Correction : additional information received clarified the explant of the device was inadvertently reported wrong.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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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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Search Alerts/Recalls
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