BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3123802 · Received May 22, 2013

    Report

    Report Number
    1644487-2013-01539
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 23, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD GENERATOR REPLACEMENT. ATTEMPTS FOR PRODUCT RETURN ARE IN PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES SINCE (B)(6) 2013 THE PATIENT WAS REFERRED TO A SURGEON FOR A CONSULT FOR A POSSIBLE GENERATOR REPLACEMENT. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE. A BATTERY LIFE CALCULATION BASED ON THE AVAILABLE PROGRAMMING HISTORY ON THE MANUFACTURER¿S PROGRAMMING HISTORY DATABASE SHOWED THAT THE GENERATOR MAY BE NEARING END OF SERVICE. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225788 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 009946

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention