BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 3213009 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10361
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY ONE MONTH POST IMPLANT, THE PATIENT WITH THIS SYSTEM EXPERIENCED A WOUND INFECTION. IN ADDITION, DEVICE INTERROGATION REVEALED NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES LOGGED WHICH CORRELATED TO SOME OF THE HOSPITAL MONITOR EVENTS. DEVICE FUNCTION WAS APPROPRIATE AS PROGRAMMED; THE DEVICE IS PACING LEFT VENTRICULAR ONLY. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR PROGRAMMING OPTIONS TO AVOID BRIEF PACEMAKER MEDIATED TACHYCARDIA. AFTER PROGRAMMING NO FURTHER EPISODES WERE LOGGED. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314091 EASYTRAK IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4512

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 4512| 0148| 4592| H195| H135