BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA (DDQP+)

    MDR report key: 4844947 · Received June 15, 2015

    Report

    Report Number
    2938836-2015-26316
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    May 7, 2015
    Report Date
    February 13, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS COULD NOT BE PERFORMED AT THIS TIME BECAUSE THE DEVICE IS NOT ACCESSIBLE FOR TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT RECEIVED AN INAPPROPRIATE THERAPY DUE TO A SVT. THE DEVICE WAS REPROGRAMMED TO ENABLE THE DISCRIMINATORS AND THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS EXPLANTED AND RETURNED FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389065 QUADRA ASSURA (DDQP+) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3265-40Q 3693723

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention