BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELIA D

    MDR report key: 7851655 · Received September 6, 2018

    Report

    Report Number
    3008973940-2018-01857
    Event Type
    Death
    Date Received
    September 6, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 6, 2018
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AND HEART FAILURE POST IMPLANT PROCEDURE WHICH INDUCED MULTIPLE ORGAN FAILURE. THE PATIENT WAS INTUBATED AND MEDICINALLY TREATED BUT THE PATIENT DIED AS A RESULT. SUBSEQUENTLY, THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN PATIENT BUT IS NO LONGER IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694813 RELIA D PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS RED01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| L 457453 LEAD, 507658 LEAD