BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 2983733 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01489
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 24, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER EXPERIENCING A SYNCOPAL EPISODE. THE ATRIAL LEAD EXHIBITED NOISE AND INTERMITTENT LOSS OF CAPTURE. THE PATIENT EXPERIENCED FEELING LIGHTHEADED. THE DEVICE WAS PROGRAMMED FROM DDDR TO VVIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87865 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR