BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 10830476 · Received November 12, 2020

    Report

    Report Number
    2017865-2020-17655
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 12, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502887
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT. 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:2017865-2020-17652. RELATED MANUFACTURER REFERENCE NUMBER:2017865-2020-17654. IT WAS REPORTED THAT THE INCISION SITE WAS INFECTED AND THE PHYSICIAN DECIDED TO REMOVE THE DEVICE AND THE LEADS AFTER SEEING THE INCISION SITE. THE PACEMAKER, ATRIAL LEAD, AND RIGHT VENTRICLE LEAD WERE ALL EXPLANTED. PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293659 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 S000074921 05414734502887

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention ASSURITY MRI| TENDRIL STS