Model Number 3788 |
Device Problems
Failure to Charge (1085); No Device Output (1435); 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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Follow-up identified surgical intervention was undertaken on (b)(4) /2015.The ipg was explanted and replaced.Effective therapy was restored postoperatively.The issue is resolved.
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Event Description
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It was reported the patient failed to recharge the ipg in the past several months due to a misplaced charger.As a result, the ipg will no longer communicate with any external devices.Surgical intervention may be undertaken as the next course of action.
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Manufacturer Narrative
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Udi(di) (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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