Model Number 3716 |
Device Problems
No Device Output (1435); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Event Description
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The patient has an scs ipg and competitor's leads.It was reported, the patient's scs ipg was inoperable.An sjm representative confirmed the issue using multiple external devices (2501 comm error from programmer).As a result, the scs ipg was explanted and replaced with a different model.The implant date is unknown for the below device: model unknown (2), scs adaptor.
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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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Additional information received identified the issue resolved with the surgical intervention.
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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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