BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1411193 · Received July 9, 2009

    Report

    Report Number
    2017865-2009-01896
    Event Type
    Injury
    Date Received
    July 9, 2009
    Date of Event
    December 9, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMAP960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED LESS THAN 110 OHMS IMPEDANCE, NO P-WAVES OR PACING, AND AN INSULATION ANOMALY. THE LEAD WAS EXPLANTED AND REPLACED.

    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/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 Required Intervention