Model Number 3788 |
Device Problem
Device Stops Intermittently (1599)
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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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It was reported the ipg is randomly turning off.The patient reports sometimes the ipg is losing charge and turning off by itself and stimulation can be resumed by using the patient programmer.The patient did not specify a particular location where the issue occurred.Surgical intervention may be pending to address this 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 information identified the patient underwent surgical intervention on (b)(6) 2016 to remove and replace the ipg.Therapy was resumed andthe patient is receiving effective stimulation.
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Search Alerts/Recalls
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