BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 4173717 · Received October 15, 2014

    Report

    Report Number
    1644487-2014-02694
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6), 2014 WERE RECEIVED WHICH INDICATED THAT THE PATIENT HAS BEEN HAVING RECURRENT SEIZURES AND THAT THE VNS BATTERY IS ¿DECREASED¿. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT. THE PHYSICIAN LATER REPORTED THAT THE PATIENT¿S VNS IS NEAR END OF SERVICE AND THAT IT WILL BE REPLACED. THE INTERVENTIONS TAKEN DUE TO THE PATIENT¿S INCREASE IN SEIZURES WERE A REFERRAL TO AN EPILEPSY CLINIC, CHANGED MEDICATIONS, AND REFERRED FOR GENERATOR REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT¿S INCREASE IN SEIZURES. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2014. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655855 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 3075

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other