Model Number 3189 |
Device Problems
Fracture (1260); High impedance (1291)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 12/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided on the final report.
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Event Description
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Related manufacturer report: 1627487-2021-00317.It was reported that patient experienced ineffective stimulation.The lead had high impedance on all contacts through one to eight.Programming changes were attempted however it was unsuccessful.Upon x-ray review, lead fracture was observed.No surgical intervention is anticipated at this time.No additional information is available at this time.
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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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New information received states that the leads were explanted.No additional information is available this time.
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Manufacturer Narrative
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H1 updated to serious injury.
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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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