BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 7893485 · Received September 20, 2018

    Report

    Report Number
    3004209178-2018-21084
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Date of Event
    September 10, 2018
    Report Date
    September 20, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00613994713650
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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 BY THE PATIENT THAT THEY WERE TOLD ''THE LEAD IS DISCONNECTED''. THE PATIENT ALSO REPORTED THAT ''WHEN I LIE DOWN FLAT, I GET A LUMP BETWEEN THE PACEMAKER AND THE CLAVICLE. WHEN I'M SITTING STRAIGHT, I DON'T HAVE THAT LUMP.'', THAT, ''THE TOP OF MY RIGHT FOOT IS NUMB AND IT GOES AWAY AT NIGHT.'' AND THAT ''ON MY ARM I'M GETTING THIS SHARP PAIN.'' THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733492 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. A2DR01 00613994713650

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR