BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP¿

    MDR report key: 7014926 · Received November 9, 2017

    Report

    Report Number
    2938836-2017-33783
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 26, 2017
    Report Date
    March 16, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PATIENT PRESENTED IN THE EMERGENCY ROOM DUE TO NOT FEELING WELL, UPON OBSERVATION OF THE BLOOD CULTURES BEING POSITIVE AND AN ECHO SHOWED POSSIBLE RV LEAD VEGETATION. PHYSICIAN DID NOT SUSPECT THE INFECTION WAS DUE TO THE DEVICE BUT RATHER THE INFECTION HAPPENED DURING THE IMPLANT PROCESS. DEVICE AND LEADS WERE EXPLANTED. NO NEW DEVICE AND LEADS WERE IMPLANTED. PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795719 QUADRA ASSURA MP¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3369-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention (B)(4)| (B)(4)| (B)(4)