Model Number 3788 |
Device Problems
Pocket Stimulation (1463); Device Operates Differently Than Expected (2913)
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Patient Problems
Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099)
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Event Date 01/10/2014 |
Event Type
Injury
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Event Description
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It was reported the patient was experiencing a surging of stimulation 2-3 times a week.The patient was able to stop the surging by pressing on the ipg pocket.Lead diagnostics showed all contacts had normal impedances.The patient underwent revision surgery where the ipg was replaced.It was discovered the ipg port plug was out and fluid was in the top header.The patient is now receiving effective stimulation without a surging sensation.
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Manufacturer Narrative
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This ipg serial number was included in a field advisory.Sjm has limited info 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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Search Alerts/Recalls
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