BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4121637 · Received September 26, 2014

    Report

    Report Number
    1644487-2014-02494
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    MODEL #, SERIAL #, LOT#, EXPIRATION DATE; CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INADVERTENTLY PROVIDED PRODUCT INFORMATION THAT WAS INCORRECT. DEVICE MANUFACTURE DATE; CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INADVERTENTLY PROVIDED PRODUCT INFORMATION THAT WAS INCORRECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GENERATOR WAS DISCARDED DURING SURGERY; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 1

    DURING A REPOSITIONING SURGERY A RECENTLY IMPLANTED GENERATOR WAS FOUND TO BE AT END OF SERVICE. IT IS BELIEVED THAT ELECTORCAUDARY WAS USED DURING THE SURGERY AND CAUSED THE END OF SERVICE CONDITION. THE GENERATOR WAS REPLACED THAT DAY AS A RESULT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE REPOSITIONING SURGERY AND THE EVENTS LEADING TO IT WILL BE REPORTED ON MEDWATCH 1644487-2014-02493

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601559 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3781

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR