BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3193118 · Received June 27, 2013

    Report

    Report Number
    1644487-2013-01950
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 5, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT¿S GENERATOR SITE WAS REALLY ¿PUFFY.¿ THE SURGEON DECIDED TO TAKE THE PATIENT TO SURGERY TO OPEN UP THE INCISION AND CLEAN THE SITE. DURING THE SURGERY, THE SURGEON NOTED DEFINITE SIGNS OF INFECTION AND EXPLANTED THE GENERATOR. THE PATIENT WAS STARTED ON ANTIBIOTICS. THE INFECTION WAS ONLY AT THE GENERATOR SITE. FOLLOW-UP SHOWED THAT THE INFECTION WAS FIRST OBSERVED ON (B)(6) 2013 DUE TO SWELLING AT THE INCISION SITE. THE RELATIONSHIP OF THE INFECTION TO VNS WAS UNKNOWN. THERE WAS NO KNOWN PATIENT MANIPULATION OR TRAUMA THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT IS WHEELCHAIR-BOUND BUT NOT THE TYPE TO PICK AT THE SITE OR DROOL. CULTURES WERE TAKEN BUT RETURNED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293507 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202464

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention