BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 3992353 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09928
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: 5076-45 LEAD, IMPLANTED: (B)(6) 2010; 5071-53 LEAD, IMPLANTED: (B)(6) 2008; 5071-53 LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A HIGH SVC COIL IMPEDANCE ALERT. A FEW DAYS LATER BOTH THE SVC COIL AND HVB COIL IMPEDANCES WERE NOTED TO BE HIGH WHEN THE SVC COIL WAS PROGRAMMED OFF WHILE IN OFFICE. THE TIP TO COIL IMPEDANCE WAS NOTED TO BE NORMAL. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE HIGH IMPEDANCE WAS DUE TO A LOOSE SET SCREW. INTERVENTION WAS PERFORMED. THE DEVICE REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472246 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R DTBA1D1 ICD