BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US

    MDR report key: 4870073 · Received June 25, 2015

    Report

    Report Number
    2938836-2015-27506
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 8, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE EPISODES OF NON-SUSTAINED RV OVERSENSING WERE OBSERVED DURING ROUTINE FOLLOW-UP. REVIEW OF THE STORED EPISODES REVEALED THAT THE DEVICE WAS UNDERSENSING ATRIAL EVENTS WHICH LED TO ATRIAL PACING, FUNCTIONAL VENTRICULAR UNDERSENSING AND LOSS OF CAPTURE. PROGRAMMING CHANGES WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412388 CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2257-40Q 3800490

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR