Model Number 3788 |
Device Problems
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 02/21/2015 |
Event Type
Injury
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Event Description
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It was reported the patient complained his scs device had no battery life and was not recharging.The patient stated his stimulation shut off, and when he attempted to charge his ipg it would not communicate.Follow-up identified a sjm representative met with the patient and confirmed the patient's scs ipg does not communicate with external devices, the ipg battery has depleted.Surgical intervention is planned for a later date to address the issue.
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Event Description
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Follow-up information identified the patient had his scs ipg explanted and replaced.Effective stimulation therapy and communication was reportedly established postoperative.The reported issue is resolved.
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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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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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