BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD XT

    MDR report key: 6470253 · Received April 6, 2017

    Report

    Report Number
    3004209178-2017-07780
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Report Date
    February 3, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169007222
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. A VISUAL INSPECTION OF THE DEVICE INTERNAL ASSEMBLY DETERMINED THAT THE LEFT VENTRICLE (LV4) FAILURE WAS DUE TO A FRACTURED LASER RIBBON BOND (LRB) FROM THE HYBRID BOND PAD ARRAY (BPA) TO THE FEEDTHROUGH FOR LVR3 (LV4). THE CAUSE OF THE FRACTURED LRBS WAS NOT DETERMINED. ICCD TEST MEASUREMENT 2 PRODUCES A FALSE FAILURE ON ALL BLACKWELL MODELS. THE FAILURE IS CAUSED BY VECTOR EXPRESS RAM WARE WHICH WRITES TO THE SAME MEMORY LOCATIONS USED BY THE ICCD TEST. THIS FALSE FAILURE HAS NO EFFECT ON DEVICES IN THE FIELD BECAUSE IT IS ONLY EXECUTED DURING DEVICE MANUFACTURING. THE VECTOR EXPRESS RAM WARE USES THIS MEMORY SPACE EXCLUSIVELY IN THE FIELD.

    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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO A HEART TRANSPLANT. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252182 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1QQ 00643169007222

    Patients

    Seq Age Sex Outcome Treatment
    1 429888 LEAD, 6935M55 LEAD, 5076-45 LEAD