Model Number 3788 |
Device Problems
Nonstandard Device (1420); 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 Date 01/05/2015 |
Event Type
Injury
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Event Description
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It was reported, the patient was unable to establish communication between his ipg and external devices.A sjm representative confirmed the issue with multiple external devices.Surgical intervention will be taken at a later date to address 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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Event Description
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Further follow up received identified the ipg was explanted.
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Search Alerts/Recalls
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