BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 2240093 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05560
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    March 23, 2011
    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
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED FROM 19 CM TO 19.5 CM FROM THE CONNECTOR PIN. THE EXPOSED COIL COULD HAVE BEEN IN CONTACT WITH THE DEVICE CAN AND MAY HAVE CAUSED THE REPORTED NOISE. ABRASIONS ARE INDICATIVE OF EXPOSURE TO CONSTANT FRICTION WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT OCCASIONALLY EXPERIENCED DIZZINESS. THE RIGHT ATRIAL LEAD EXHIBITED NOISE AND OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention