BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 5151456 · Received October 15, 2015

    Report

    Report Number
    2017865-2015-29437
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 29, 2015
    Report Date
    September 29, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE ATRIAL LEAD, CAPTURE AND SENSING VALUES COULD NOT BE OBTAINED. IMPEDANCE MEASUREMENTS WERE LOW AS WELL. THE LEAD WAS REMOVED AND A REPLACEMENT LEAD WAS IMPLANTED. DURING REMOVAL OF THE LEAD, THERE WAS DIFFICULTY INSERTING A STYLET INTO THE LEAD. UPON REMOVAL, A KINK IN THE LEAD'S BODY WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683057 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 A000008108

    Patients

    Seq Age Sex Outcome Treatment
    1