ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
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Model Number 3186 |
Device Problem
Migration (4003)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 07/20/2020 |
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 in the final report.
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Event Description
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Related manufacturer reference number 3006705815-2020-30403.It was reported that patient experienced undesired nerve stimulation.X-rays confirmed that the leads had migrated.As a result, surgical intervention was undertaken on (b)(6) 2020, wherein the leads were explanted and replaced.Effective therapy was restored post operatively.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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