BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 4061830 · Received September 4, 2014

    Report

    Report Number
    2938836-2014-15547
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 3, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EPISODES OF NON-SUSTAINED RV OVERSENSING WERE OBSERVED VIA REMOTE TRANSMISSION. THE PATIENT PRESENTED TO THE ER, WHERE THE OVERSENSING WAS NOT REPRODUCIBLE. PROGRAMMING CHANGES WERE MADE. SUBSEQUENTLY, ANOTHER EPISODE OF NON-SUSTAINED RV OVERSENSING WAS OBSERVED VIA REMOTE TRANSMISSION. PATIENT WAS ASYMPTOMATIC. REVIEW OF THE EGM REVEALED POSSIBLE MYOPOTENTIAL OVERSENSING. NO PATIENT SYMPTOMS WERE REPORTED. PROGRAMMING CHANGES WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540864 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3267-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR 7122Q/58, (B)(4)