Model Number 3788 |
Device Problems
Use of Device Problem (1670); 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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It was reported the patient did not charge /use the scs ipg for about 6 months.In turn, the ipg is unable to communicate with external devices.Surgical intervention will be taken at a later date to address the issue.Date of event unknown.
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Event Description
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Further follow up identified the ipg was explanted and replaced with a different model which resolved the issue.
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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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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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