BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 2983832 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01440
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 8, 2013
    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
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLUOROSCOPY REVEALED THAT THE RIGHT VENTRICULAR LEAD WAS ABRADED. NO ELECTRICAL ANOMALIES WERE NOTED. THE PHYSICIAN ELECTED TO CAP AND REPLACE THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88329 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR