BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 13026731 · Received December 17, 2021

    Report

    Report Number
    2017865-2021-39420
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    December 9, 2021
    Report Date
    December 17, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    UDI-DI
    05414734503259
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES. REVIEW OF THE STERILIZATION RECORDS CONFIRMED NORMAL STERILIZATION CYCLES FOR THE PRODUCTS. THE CAUSE OF INFECTION COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    9833234 - RELATED MANUFACTURING REPORT NUMBER: 2017865-2021-39418, CAU294330 - RELATED MANUFACTURING REPORT NUMBER: 2017865-2021-39419. IT WAS REPORTED THAT A BLOOD TEST REVEALED THAT A PATIENT HAD ENDOCARDITIS. THE PHYSICIAN ELECTED TO EXPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), ATRIAL LEAD, AND RIGHT VENTRICULAR (RV) LEAD. THE PATIENT CONDITION WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923656 DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7170Q/58 S000029950 05414734503259

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention BIOTRONIK LEFT VENTRICULAR LEAD