Model Number 1192 |
Device Problem
Fracture (1260)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 05/01/2020 |
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 when the evaluation is completed.
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Event Description
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Related mfr reports: 1627487-2020-32378, 1627487-2020-32379 and 1627487-2020-32380.It was reported surgical intervention was taken to replace the patient's fractured scs system leads.Reportedly, during the procedure the lead anchors were found broken in half.Both leads and anchors were replaced and the reported issue addressed.No patient adverse consequences were reported.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
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Event Description
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Related mfr reports: 1627487-2020-32378, 1627487-2020-32379 and 1627487-2020-32380.
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Search Alerts/Recalls
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