Model Number 3186 |
Device Problems
Disconnection (1171); High impedance (1291)
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Patient Problems
Fall (1848); Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)
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Event Date 04/23/2018 |
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 3.Reference mfr.Report: 1627487-2018-04682, reference mfr.Report: 3006705815-2018-01077.It was reported the patient experienced ineffective stimulation from the scs thoracic system after the patient fell.Diagnostics revealed high impedances, and x-rays confirmed the leads have pulled out of the ipg header.Reprogramming attempts have been unsuccessful, therefore the patient may be awaiting surgical intervention.
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Event Description
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Additional information received indicated that the patient underwent surgical intervention on an unknown date a couple years ago wherein the scs system was explanted and replaced with another manufacturer's, nuvectra, system.Further information is unavailable at this time.
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Manufacturer Narrative
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The event of leads pulled out of header was reported to abbott.The patient experienced ineffective stimulation from the scs thoracic system after the patient fell.Patient was evaluated and high impedance was detected during an impedance check.X-rays confirmed the leads have pulled out of the ipg header.Reprogramming attempts were unsuccessful.The scs system was explanted and replaced with another manufacturer's system.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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