BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 6103119 · Received November 15, 2016

    Report

    Report Number
    2017865-2016-07170
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    September 16, 2016
    Report Date
    October 4, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD DISLODGEMENT WAS OBSERVED. AN IMPEDANCE ISSUE AND NO CAPTURE WERE ALSO NOTED. THE LEAD WAS REPOSITIONED AND REMAINS IMPLANTED AND ACTIVE. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754617 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 A000025115

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention