BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2801936 · Received October 23, 2012

    Report

    Report Number
    1644487-2012-02705
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED.REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT HAD DEBRIDEMENT SURGERY AT THE VNS GENERATOR SITE ON (B)(6)2012 DUE TO INFECTION. THE GENERATOR WAS NOT EXPLANTED.THE PATIENT IS CURRENTLY DOING VERY WELL AND WAS RECENTLY SEEN. THE INFECTION IS RESOLVING AND THE PATIENT IS HEALING. THE PATIENT HAS COMPLETED HER COURSE OF ANTIBIOTICS AND HAS BEEN RELEASED BACK TO THE CARE OF NEUROLOGY, AND WILL FOLLOW UP WITH THE SURGEON ONLY IF NEEDED. THE PATIENT HAD NO TRAUMA, BUT SHE DOES DROOL A LOT, AND THIS MAY HAVE BEEN A FACTOR IN THE INFECTION. IT IS ALSO POSSIBLE THE PATIENT MAY HAVE PICKED AT THE INCISION. CULTURES OF THE WOUND WERE PERFORMED, BUT THERE WAS NO GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS INC 103 201958

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention