BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP¿

    MDR report key: 9722853 · Received February 18, 2020

    Report

    Report Number
    2017865-2020-02253
    Event Type
    Injury
    Date Received
    February 18, 2020
    Date of Event
    January 31, 2020
    Report Date
    February 18, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508377
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR EXPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DUE TO POCKET EROSION. THE DEVICE AND ALL LEADS WERE REMOVED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184272 QUADRA ASSURA MP¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000069720 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention