BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA¿ QUAD XT CRT-D

    MDR report key: 8685120 · Received June 10, 2019

    Report

    Report Number
    3004209178-2019-11273
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    January 6, 2019
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169007222
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    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 THERE WAS INAPPROPRIATE HIGH VOLTAGE THERAPY PROVIDED DURING AN ATRIAL ARRHYTHMIA. THE PATIENT IS REPORTED TO HAVE RECEIVED NINE SHOCKS FOR A HEART RATE IN THE VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) ZONE WHEN THE PATIENT WAS IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE PATIENT WAS TREATED WITH ANTIARRHYTHMIC AND ANTICOAGULATION MEDICATION AND THE DEVICE DETECTION INTERVALS WERE ADJUSTED. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXPERIENCED UNDERSENSING ON STORED ELECTROGRAMS (EGM). THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477603 VIVA¿ QUAD XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1QQ 00643169007222

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R