BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3942441 · Received July 17, 2014

    Report

    Report Number
    1644487-2014-01824
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    October 17, 2018
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GENERATOR REPOSITIONING SURGERY FOR PATIENT COMFORT THE BOVIE MADE CONTACT WITH THE PATIENT'S GENERATOR CAUSING THE GENERATOR TO SHOW NEAR END OF SERVICE. THE GENERATOR WAS EXPLANTED AND A NEW GENERATOR WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419182 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 202174

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR