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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pneumonia (2011); No Code Available (3191)
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Event Date 12/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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Uchida, d & yamamoto, t.(2017).Experience and solution of complications of vagus nerve stimulation therapy in 139 implant patients.No shinkei geka, 45(12):1051-1057.Doi: 10.11477/mf.1436203646.
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Event Description
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A research article comprised of data from a hospital's registry of all vns patients implanted between december 2010 and march 2016 reported several adverse events.This report captures the adverse events attributed to the generator in the abstract of the article.The adverse events attributed to the lead in the article abstract are captured in mfr.Report # 1644487-2018-00123.One patient experienced aspiration pneumonia subsequent to recurrent nerve paralysis (captured in mfr report 1644487-2018-00123).Another patient reportedly rotated the generator beneath the skin, resulting in a lead fracture and subsequent vns explant surgery.Three patients experienced surgical site infections which resulted in vns explant surgeries.Per the article, the incidence rate of infections reported was 2.2%.It was reported that an allergic reaction to the vns device may have caused one of the observed infections.No additional relevant information has been received to date.
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Event Description
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A company representative received identifying patient information from the authoring physicians of the article for the patients who experienced surgical-site infections and generator migration and subsequent lead fracture, originally captured in this report, mfr.Report #1644487-2018-00122.It was determined that the infections were previously reported to the manufacturer and are captured in mfr.Report # 1644487-2013-02562, # 1644487-2013-03225, and # 1644487-2015-06368.The reported patient-influenced migration and subsequent lead fracture was previously reported to the manufacturer and is captured within mfr.Report # 1644487-2018-00289.No additional relevant information has been received to date.
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Search Alerts/Recalls
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