BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 8705900 · Received June 17, 2019

    Report

    Report Number
    2017865-2019-09707
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    June 3, 2019
    Report Date
    July 16, 2019
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED ENDOCARDITIS AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT'S CONDITION WAS FURTHER COMPLICATED BY MULTIPLE OPEN SKINS SORES AND SEMI-RECENT AMPUTATION OF THE FINGERS AND LOWER EXTREMITIES. THE PATIENT WAS SCHEDULED FOR REMOVAL OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM. THE PRIMARY INDICATION FOR THE PROCEDURE WAS TO REMOVE VEGETATION ATTACHED TO THE CHRONIC ATRIAL LEAD. ON (B)(6) 2019, THE PATIENT PRESENTED FOR THE PROCEDURE. TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED AND FOUND NO ENDOCARDIAL VEGETATION THAT WAS INDICATED FOR THE PROCEDURE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS REMOVED WITHOUT FURTHER COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE WELL. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-09706, 2017865-2019-09708, 2017865-2019-09709.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498287 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000046047 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O| R