BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2974018 · Received February 22, 2013

    Report

    Report Number
    1644487-2013-00477
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 24, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE PATIENT WOULD JERK HIS HEAD AND THAT HIS SEIZURE PATTERNS HAVE CHANGED WHILE THE VNS BATTERY WAS REPORTEDLY DEPLETED. THE PROGRAMMING HISTORY DATABASE WAS REVIEWED AND IT WAS NOTED THAT THE PHYSICIAN HAD THE PATIENT SET ON A 57% DUTY CYCLE FROM DATE (B)(6) 2011 WHICH IS CONSIDERED AS EXCESSIVE. THE PHYSICIAN WAS CONTACTED, BUT DID NOT RESPOND TO DATE. SURGERY TO REPLACE THE VNS GENERATOR IS LIKELY, BUT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PATIENT IS TAKING SIX DIFFERENT MEDICATIONS WHICH IS MAKING HIM SLEEP A LOT AND MADE HIM LOSE A LOT OF WEIGHT. IT ALSO INDICATED THAT THE PATIENT'S SEIZURES HAVE DECREASED AFTER THE VNS BATTERY DEPLETED AND THE PARENT PREFERS NOT TO REVISE THE VNS. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT WAS CLEARED FOR SURGERY AND THE SURGERY DATE WAS SCHEDULED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT'S VNS GENERATOR WAS REPLACED. THE EXPLANTED GENERATOR WILL NOT BE RETURN AS THE SITE DOES NOT RETURN EXPLANTED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77741 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016389

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other| R