BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3113188 · Received May 15, 2013

    Report

    Report Number
    1644487-2013-01371
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT PRESENTED TO THE HOSPITAL WITH INCREASED SEIZURES. THE REPORTER ¿DID NOT HAVE AN OPINION¿ ON THE RELATIONSHIP OF THE INCREASED SEIZURES TO THE VNS DEVICE. THE PATIENT IS NO LONGER BEING SEEN BY THE REPORTER DUE TO INSURANCE REASONS. THE PATIENT¿S CAREGIVER ALSO REPORTED TO THE MANUFACTURER THAT THE PATIENT¿S SEIZURES WERE INCREASED TO ABOVE PRE-VNS BASELINE LEVELS. THE MANUFACTURER ASSISTED THE CAREGIVER IN FINDING VNS-TREATING PHYSICIANS FOR THE PATIENT TO CHECK THE VNS, BUT IT IS UNKNOWN IF THE PATIENT HAS FOLLOWED UP WITH ANYONE FOR CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215641 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 2542

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR