BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1940564 · Received December 21, 2010

    Report

    Report Number
    1644487-2010-02865
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A REFERRAL REQUEST FORM THAT A VNS PATIENT WAS TO UNDERGO VNS BATTERY CHANGE AND RE-POSITION. FOLLOW-UP WAS MADE WITH THE PATIENT'S TREATING NURSE WHO INDICATED THE PATIENT WAS REFERRED FOR BATTERY REPLACEMENT AS THE PATIENT WAS HAVING AN INCREASE IN SEIZURES. THE PATIENT AT THE TIME OF THE INCREASE WAS SWITCHED TO NEW MEDICATIONS; HENCE, THE RELATIONSHIP TO VNS THERAPY WAS UNKNOWN AS WELL AS PRE-VNS LEVELS. ADDITIONALLY, PER THE TREATING NURSE, THE LAST KNOWN DIAGNOSTICS WERE FROM (B)(6) 2010 AND WERE WITHIN NORMAL LIMITS. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY AS SCHEDULED AND GOOD FAITH ATTEMPTS TO OBTAIN THE EXPLANTED GENERATOR HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 011188

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention