BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 16787472 · Received April 21, 2023

    Report

    Report Number
    2017865-2023-18145
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    March 29, 2023
    Report Date
    May 18, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502894
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-18143, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-18144. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM ¿ PACEMAKER, RIGHT VENTRICULAR LEAD AND ATRIAL LEAD. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964623 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/58 A000047573 05414734502894

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention