BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 4163462 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19244
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CARDIOLOGIST HAD "DECIDED TO SHUT OFF, OR AT LEAST REDUCE THE PACING IN THE BOTTOM QUADRANT OF MY HEART." SINCE THAT DEVICE CHECK, THE PATIENT HAS " NOTICED FLUTTERING IN MY CHEST AND CAN FEEL MY PULSE IN MY THROAT". THE PATIENT WAS SEEN IN THE EMERGENCY ROOM TO RESOLVE THE ISSUE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640124 VERSA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R 4068-52 LEAD, 4024-58 LEAD