BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 8842720 · Received July 30, 2019

    Report

    Report Number
    2017865-2019-11555
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    June 24, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    UDI-DI
    05414734503341
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-11554, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-11557. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH EROSION. THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD ERODED THROUGH THE POCKET AND WAS EXPOSED, CAUSING AN INFECTION. ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2019. PATIENT CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637573 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7122Q/65 A000036539 05414734503341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention QUADRA ASSURA CRT-D QUAD RF HV| QUARTET