Model Number 3228 |
Device Problem
Fracture (1260)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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Event date is estimated.
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Event Description
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It was reported the patient experienced ineffective stimulation and x-rays indicated the lead was fractured.The patient reported having a recent fall.Surgical intervention is planned to address the issue.
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Event Description
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It was reported the patient experienced ineffective stimulation and x-rays indicated the lead was fractured.As a result, the patient's lead was explanted and replaced.Surgical intervention resolved the patient's issue.
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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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Search Alerts/Recalls
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