BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD XT

    MDR report key: 5133160 · Received October 7, 2015

    Report

    Report Number
    3004209178-2015-19261
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 20, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT PRODUCT: A7700-21 MECHANICAL VALVE; M7700-33 MECHANICAL VALVE, IMPLANTED: (B)(6) 1990. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POST-OPERATIVE DEVICE INDUCTION TEST, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT DELIVER THE SHOCK, WHICH REQUIRED THE PATIENT TO BE RESCUED EXTERNALLY. A SECOND ATTEMPT WAS MADE, AND THE DEVICE DETECTED AND TREATED THE INDUCED RHYTHM SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THE COMPANY REPRESENTATIVE MAY HAVE INADVERTENTLY SELECTED THE 'SUSPEND' BUTTON DURING THE FIRST EPISODE. 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
    664271 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR