BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3790294 · Received May 5, 2014

    Report

    Report Number
    1644487-2014-01194
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    December 1, 2010
    Report Date
    April 9, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT HAD INTERMITTENT PAIN AT HER IMPLANT SITE AND DEVELOPED A POST-OPERATIVE INFECTION AT HER IMPLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266437 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other