BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 4123462 · Received September 26, 2014

    Report

    Report Number
    1644487-2014-02499
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT DUE TO NEAR END OF SERVICE. THE PHYSICIAN BELIEVES THAT THE INCREASE IN SEIZURES ARE MOST LIKELY UNRELATED TO VNS THERAPY. IT WAS REPORTED THAT THE PATIENT MAY BE PREGNANT WHICH MAY HAVE CONTRIBUTED TO THE INCREASE IN SEIZURES. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPLANTED DEVICE WAS DISCARDED; THEREFORE, PRODUCT ANALYSIS CAN NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY SHOWED NORMAL DIAGNOSTIC RESULTS THROUGH (B)(6) 2012. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY APPROXIMATELY 1.7 YEARS UNTIL NEOS = YES. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WILL BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602347 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 200975

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention