Model Number 3186 |
Device Problems
High impedance (1291); Material Twisted/Bent (2981)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 05/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer reference number: 3006705815-2021-03181.It was reported that the patient's lead was displaying high impedances.Reprogramming was unable to resolve the issue.Surgical intervention is anticipated.It is unknown which lead is displaying high impedances so both are being reported on.
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Event Description
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It was reported that the physician explanted and replaced the patient's leads.Reportedly, one lead was displaying high impedances and the other was bent.Surgical intervention resolved the 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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