BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2972969 · Received February 21, 2013

    Report

    Report Number
    1644487-2013-00478
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 22, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT FELT THAT THEY WERE EXPERIENCING ERRATIC STIMULATION. THE PATIENT HAD A RECENT GENERATOR REPLACEMENT DUE TO REPORTED BATTERY DEPLETION BUT IT IS UNKNOWN IF IT WAS ALSO DONE DUE TO THE ERRATIC STIMULATION. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN AND ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76366 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS INC 101 5423

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention