BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 8595474 · Received May 9, 2019

    Report

    Report Number
    2017865-2019-06695
    Event Type
    Injury
    Date Received
    May 9, 2019
    Report Date
    June 19, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    UDI-DI
    05414734502818
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. CONCOMITANT MEDICAL PRODUCTS: QUADRA ASSURA MP ICD, TENDRIL STS LEAD, AND QUARTET LEAD.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-06692, 2017865-2019-06693, AND 2017865-2019-06696. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC ON (B)(6) 2019 WITH OPENED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SITE. THE DEVICE HEADER AND LEADS WERE EXPOSED. THE PATIENT STATED THAT THE SITE OPENED SHORTLY AFTER DEVICE REPLACEMENT PROCEDURE. THE PATIENT RECEIVED ANTIBIOTICS. THE WHOLE SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTED THAT THE SYSTEM WAS EXPLANTED ON APRIL 29, 2019. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388528 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7120Q/58 4024470 05414734502818

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention