BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIA AF XT VR

    MDR report key: 11405336 · Received March 3, 2021

    Report

    Report Number
    3004209178-2021-03604
    Event Type
    Injury
    Date Received
    March 3, 2021
    Date of Event
    December 1, 2019
    Report Date
    March 3, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    UDI-DI
    00643169566347
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 HAD "AN INCIDENT" WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT STATED THEY "HAD AN ANGIO, IT DID NOT TURN ON. I WAS OUT FOR THIRTY-EIGHT SECONDS." PATIENT WENT ON TO STATE THAT "THE NURSE WAS POUNDING ON MY CHEST" AND "I COULD HAVE DIED ON THE TABLE. THE DOCTOR IS TELLING ME IT TRIED TO CORRECT ITSELF AND IT CAME ON. I DIDN'T FEEL A SHOCK I DIDN'T FEEL ANYTHING." THE DEVICE REMAINS 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
    302245 VISIA AF XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DVAB1D1 00643169566347

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening 6944-58, LEAD