BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 4860802 · Received June 22, 2015

    Report

    Report Number
    2938836-2015-26861
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 21, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DEVICE RECORDED UPPER OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE MEASUREMENTS. THE DEVICE IS NOW ERI. THE PHYSICIAN PLANS TO PERFORM A DEVICE CHANGE-OUT AND EVALUATE THE HVLI WITH THE NEW CAN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404356 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 3207-36

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR