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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The physician reported the patient presented to the emergency room.Per the sjm representative, the patient's ipg was inoperable (loss of communication).It is unknown when the patient lost stimulation and when the ipg was last recharged.Surgical intervention is planned as the next course of action.
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Event Description
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Follow-up identified the patient experienced difficulty charging the ipg, and failed to charge the ipg regularly.The ipg became inoperable thereafter.Surgical intervention was undertaken to explant and replace the ipg.Effective stimulation was restored post-operatively.
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Search Alerts/Recalls
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