BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP¿

    MDR report key: 6654711 · Received June 20, 2017

    Report

    Report Number
    2938836-2017-29399
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    May 22, 2017
    Report Date
    September 28, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS TO REPORT AN ADDITIONAL METHOD CODE.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT WAS NOT CONFIRMED IN THE LABORATORY. INTERROGATION OF THE DEVICE REVEALED IT WAS ABOVE ERI WHEN RECEIVED. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE AND LEADS WERE EXPLANTED DUE TO STAPH INFECTION. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE & POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433675 QUADRA ASSURA MP¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3369-40Q UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention