BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4131361 · Received October 1, 2014

    Report

    Report Number
    1644487-2014-02524
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    September 8, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECENTLY IMPLANTED VNS PATIENT UNDERWENT SURGERY ON (B)(6) 2014 TO EXPLANT HIS GENERATOR AND LEAD. THE PATIENT HAD BEEN SCRATCHING AT HIS CERVICAL WOUND SITE WHICH SUBSEQUENTLY LED TO EXTRUSION OF THE ELECTRODE. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF COMBATIVENESS, AGGRESSIVENESS, AND SELF-MUTILATING BEHAVIOR. THE PATIENT WENT TO THE ER WHERE APPROXIMATELY 6CM OF THE PATIENT¿S LEAD WAS FOUND TO BE VISIBLY EXTRUDING FROM THE APPROXIMATE 6MM OPENING OF THE PATIENT¿S WOUND. THERE WAS NO PURULENCE BUT THE PATIENT WAS SENT FOR SURGERY DUE TO RISK OF INFECTION. DURING EXPLANT, GRANULATION TISSUE WAS FOUND AT THE AREA OF DEHISCENCE AND A SIGNIFICANT AMOUNT OF SCARRING WAS NOTED WITHIN THE PATIENT¿S NECK. THE EXTRUDING PORTION OF THE PATIENT¿S LEAD WAS CUT AND DISCARDED. SAMPLES WERE TAKEN FOR CULTURES AND THE PATIENT¿S WOUND WAS CLEANED AND IRRIGATED. THE PATIENT HAS NOT BEEN RE-IMPLANTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611968 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS INC 105 202828

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention