BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3904292 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08898
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THESE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS EXHIBITED HIGH PACING THRESHOLDS AND LOSS OF CAPTURE (LOC). X-RAY REVEALED THAT BOTH LEADS WERE DISLODGED. A REVISION PROCEDURE WAS PERFORMED WHEREIN BOTH LEADS WERE REPOSITIONED SUCCESSFULLY WITH GOOD MEASUREMENTS. FOLLOWING THE PROCEDURE, DIAPHRAGMATIC STIMULATION WAS OBSERVED AND LV OUTPUT WAS ADJUSTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384262 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R W173| 4457| 4543