BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1955423 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00822
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 4, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE LEAD FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AT 19.2 CM TO 19.7 CM FROM THE CONNECTOR PIN. THE DAMAGE INDICATES THAT THE LEAD ABRADED AGAINST ANOTHER DEVICE.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICULAR LEAD EXHIBITED NOISE. THE PATIENT WAS PACEMAKER DEPENDENT, AND REPORTED BEING SYMPTOMATIC IN THE PAST MONTH. THE LEAD WAS EXPLANTED AND REPLACED. VISUAL INSPECTION OF THE EXPLANTED LEAD FOUND OUTER INSULATION DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention (B)(4)