Model Number 3716 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 03/01/2016 |
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.
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Event Description
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It was reported the patient has not used her ipg in over 9 months.As a result, the device is now inoperable.Subsequently, 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 the ipg was explanted and replaced with a different model.
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Search Alerts/Recalls
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