Model Number 3228 |
Device Problem
High impedance (1291)
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Patient Problems
Twiddlers Syndrome (2114); Inadequate Pain Relief (2388)
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Event Date 04/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 1 of 2, reference mfr.Report#: 1627487-2018-04927.It was reported the patient lost effective stimulation.High impedances were notes and x-rays confirmed the lead was coiled up due to the patient twiddling the ipg.The patient underwent surgical intervention where the lead was replaced with a new one and the ipg was implanted deeper into the pocket and sutured down.
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Event Description
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Device 1 of 2: reference mfr.Report#: 1627487-2018-04927.Follow up information identified the patient is now receiving effective stimulation.
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Search Alerts/Recalls
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