BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD S

    MDR report key: 3991656 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14257
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- THE DEVICE WAS NOT RETURNED HOWEVER, ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: 419688 LEAD IMPLANTED: 2013 (B)(6); 6947M-62 LEAD IMPLANTED: 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD NO CAPTURE. AFTER THE REPROGRAMMED WAS PERFORMED, IT WAS NOTED THAT THE IMPEDANCE HAD INCREASED ON THE LEAD AND THE LONGEVITY ESTIMATION WAS SHORTER THAN EXPECTED. THE LEAD AND DEVICE REMAIN 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
    471121 VIVA QUAD S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention 5076-52 LEAD