Model Number 3688 |
Device Problem
Device Inoperable (1663)
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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).
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Event Description
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It was reported the patient ((b)(6)) is unable get his ipg to communicate with the programmer due to the ipg being inoperable.A replacement programmer was tried to address the issue but was unsuccessful.As a result, the patient will undergo surgical intervention to address the issue.
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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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Event Description
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Follow-up revealed the patient's ipg was explanted and replaced (with a different model).Surgical intervention resolved the patient's issue.
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Search Alerts/Recalls
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