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 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 sjm representative met with the patient and determined the ipg is unable to communicate with multiple external devices.The patient has been without stimulation for three months.The patient was recharging for one hour per week and has been unable to recharge despite numerous attempts.Surgical intervention may be pending to address this issue.Date of event is unknown.
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Event Description
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Follow up information identified the patient underwent surgical intervention to remove and replace the ipg which resolved the issue.Therapy has been restored.
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Search Alerts/Recalls
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