BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 5233738 · Received November 18, 2015

    Report

    Report Number
    2017865-2015-30281
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 28, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    NEW INFORMATION INDICATED THAT THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2015. THE PATIENT WAS STABLE POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED IN CLINIC AND THE VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE AND HIGH THRESHOLD. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764948 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1488TC/52 0002395295

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention