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 11/11/2019 |
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 manufacturer report number: 3006705815-2020-00017.It was reported that the patient recently had a fall, after which they began experiencing auto reducing and the lead was found to have high impedances.X-ray showed a possible lead pullout.In turn, surgical intervention may take place to address 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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Event Description
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Additional information revealed that the patient underwent surgical intervention wherein the lead was explanted and replaced.Postoperatively, the patient has effective therapy.
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Search Alerts/Recalls
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