BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3905608 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11775
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCES GREATER THAN 2,000 OHMS AT FOLLOW UP. LV THERAPY WAS PROGRAMMED OFF UNTIL A REVISION PROCEDURE TOOK PLACE THE FOLLOWING DAY WHEREIN THE LV LEAD WAS SURGICALLY ABANDONED AND REPLACED IN ADDITION TO THE DEVICE BEING UPGRADED TO A QUADRIPOLAR SYSTEM. THE CAUSE OF THE OUT OF RANGE IMPEDANCES WAS NOT DETERMINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD AND CRT-D ARE NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383948 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0296| 4543| 4095| P108