BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 7675688 · Received July 10, 2018

    Report

    Report Number
    2017865-2018-10073
    Event Type
    Injury
    Date Received
    July 10, 2018
    Date of Event
    June 28, 2018
    Report Date
    August 2, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    UDI-DI
    05414734508377
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE HOE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM, INCLUDING THE ATRIAL, RIGHT VENTRICULAR AND LEFT VENTRICULAR LEADS WERE EXPLANTED DUE TO THE INFECTION. THE PATIENT WAS STABLE THROUGHOUT THE WHOLE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516238 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000046033 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention