Model Number 3228 |
Device Problems
Disconnection (1171); High impedance (1291)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 11/21/2019 |
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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Related manufacturing report number: 1627487-2020-00987.It was reported that the patient's stimulation was decreasing by itself.Troubleshooting confirmed the system was autoreducing.Follow up identified that one of the leads disconnected causing high impedances on a lead.Surgical intervention may be pending for this 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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Event Description
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Follow up identified that the patient underwent surgical intervention wherein the leads were explanted and replaced, restoring therapy.
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Search Alerts/Recalls
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