BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 8705300 · Received June 17, 2019

    Report

    Report Number
    1644487-2019-01153
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 24, 2019
    Report Date
    August 22, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750054
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MEDICAL RECORDS FOR THE PATIENT WERE RECEIVED FROM THE DATE THE GENERATOR WAS IMPLANTED INDICATING A 2-0 SILK SUTURED WAS USED TO SECURE BOTH THE LEAD AND GENERATOR WHEN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REFERRED FOR SURGERY DUE TO THE PATIENT NOT LIKING HIS VNS MOVING AROUND IN HIS CHEST. DURING THE SURGERY, THE GENERATOR POCKET WAS MADE DEEPER AND THE SAME GENERATOR WAS RE-IMPLANTED IN THE PATIENT. THE LEAD WAS CONNECTED BACK TO THE GENERATOR AND INTERROGATION/SYSTEM DIAGNOSTICS WERE PERFORMED WITH LEAD IMPEDANCE AND BATTERY BEING GOOD. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497693 PULSE GEN MODEL 105 GENERATOR LYJ LIVANOVA USA, INC. 105 203211 05425025750054

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention