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 Date 12/18/2015 |
Event Type
Injury
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Manufacturer Narrative
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This ipg serial number was included in a field advisory.(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.Udi (di): (b)(4).
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Event Description
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It was reported the patient lost stimulation and is unable to establish communication between her ipg and external devices.The patient will undergo surgical intervention as the next course of action.
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Event Description
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Follow-up information revealed the patient underwent surgical intervention where her ipg was explanted and replaced with a different model.The patient reported effecitve therapy postoperative.
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Search Alerts/Recalls
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