Model Number 3386 |
Device Problem
Impedance Problem (2950)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/04/2019 |
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 reference number: 3006705815-2019-03275.Related manufacturer reference number: 1627487-2019-09772.Related manufacturer reference number: 1627487-2019-09776.Related manufacturer reference number: 3006705815-2019-03278.Related manufacturer reference number: 1627487-2019-09781.It was reported that the patient experienced loss of stimulation.Diagnostics indicated multiple high and low impedance values.X-rays indicated there might be a slight pull out of the header.Surgical intervention may be pending.
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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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Further follow-up indicates an extension was explanted on (b)(6) 2019.
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Search Alerts/Recalls
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