BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURE QUADRA RF

    MDR report key: 4072322 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16305
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    May 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE PULSE GENERATOR WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556118 ALLURE QUADRA RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM3242 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention (B)(4)