BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL DX

    MDR report key: 2983661 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01375
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 1, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER EXPERIENCING SYNCOPAL EPISODES. THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE, NOISE AND WAS FRACTURED. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85722 TENDRIL DX PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1388TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention