Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Seizures (2063); Inadequate Pain Relief (2388)
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Event Date 06/24/2017 |
Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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: 1627487-2017-07553.It was reported the patient had a seizure and hit her head.The lead migrated, as confirmed by x-rays, and the patient felt ineffective stimulation.As a result, the patient underwent lead replacement.Effective therapy was restored post-op.
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Manufacturer Narrative
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Explant date has been corrected.
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Event Description
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Device 1 of 2, reference mfr.Report: 1627487-2017-07553.
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Search Alerts/Recalls
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