Model Number 3788 |
Device Problems
Nonstandard Device (1420); Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/07/2016 |
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.(b)(4).
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Event Description
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It was reported the patient's ipg is inoperable.It was also reported the patient has not recharged the ipg in approximately 4 years.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 informatin revealed the patient underwent surgical intervention where the ipg was explanted and replaced with a different model.The patient reported effective therapy postoperaive.
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Search Alerts/Recalls
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