BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA S

    MDR report key: 6005493 · Received October 6, 2016

    Report

    Report Number
    3004209178-2016-20675
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    July 22, 2016
    Report Date
    July 22, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 694765 LEAD, IMPLANTED (B)(6) 2009.

    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 THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED. INTERROGATION SHOWED THERE WAS NINE MONTHS REMAINING LONGEVITY AND THE DEVICE WAS IMPLANTED JUST OVER A YEAR AGO. 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
    655368 VIVA S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 511212 UNKNOWN LEAD