Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Pain (1994)
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Event Date 10/03/2018 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Device 1 of 2; related manufacturer reference number: 1627487-2019-07221.It was reported that the patient¿s anchors were protruding near the lead site.The patient had a fall.As a result, surgical intervention took place on (b)(6) 2019 wherein the physician buried the anchors deeper.Therapy has been restored post-op.
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Manufacturer Narrative
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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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Event Description
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Device 1 of 2 related manufacturer reference number: 1627487-2019-07221.
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Search Alerts/Recalls
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