BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 15048463 · Received July 18, 2022

    Report

    Report Number
    2017865-2022-15406
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    June 27, 2022
    Report Date
    August 15, 2022
    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
    JA
    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 INSPECTION 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 PRODUCT WAS RETURNED AND VISUAL INSPECTION WAS NORMAL. THE CAUSE OF INFECTION COULD NOT BE TRACED TO THE DEVICE.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-15404; RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-15405. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH SKIN EROSION AND INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN WAS ALSO CONCERNED ABOUT THE BACKFLOW OF BLOOD INSIDE OF THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS. THE PACEMAKER, RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR WERE EXPLANTED DUE TO INFECTION. THE PATIENT EXPERIENCED NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241536 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/58 P000136361 05414734502894

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention