Model Number 3186 |
Device Problem
Disconnection (1171)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 08/27/2018 |
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 2 of 3; reference mfr report: 1627487-2018-08663, reference mfr report: 3006705815-2018-02252.It was reported the patient experienced overstimulation at the ipg site.Fluoroscopy imaging revealed the leads had pulled out of the ipg header.Surgical intervention was undertaken on 28aug2018 and a replacement ipg and leads were implanted.
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Event Description
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Device 2 of 3 : reference mfr report: 1627487-2018-08663; reference mfr report: 3006705815-2018-02252.Additional information received indicated the patient's scs system was explanted and replaced.Postoperatively, the patient is reportedly receiving effective therapy.
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Search Alerts/Recalls
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