Model Number 3186 |
Device Problem
High impedance (1291)
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Patient Problems
Fall (1848); Inadequate Pain Relief (2388)
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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 2.Reference mfr.Report#3006705815-2018-01745.It was reported the patient's scs system would not enter into mri mode after suffering multiple falls.Reportedly, diagnostic testing revealed high impedances on several lead contacts.As a result, surgical intervention may be undertaken as the next course of action.
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Event Description
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Device 2 of 2 reference mfr.Report#3006705815-2018-01745.Follow-up identified surgical intervention was undertaken wherein both leads were explanted and replaced with two new leads.Postoperatively, stimulation was restored thus resolving the issue.
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Search Alerts/Recalls
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