BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2942144 · Received February 4, 2013

    Report

    Report Number
    1644487-2013-00281
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(4) 2013, A PHYSICIAN REPORTED THAT THIS VNS PATIENT WAS HAVING AN INCREASE IN SEIZURES. NO INFORMATION WAS AVAILABLE AS THIS WAS NOT THE PATIENT'S FOLLOWING PHYSICIAN. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. A BATTERY LIFE CALCULATION INDICATED 9.77 YEARS REMAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46160 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 2555

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR