BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2173685 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11185
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS COMPLETE TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILBLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE LEFT VENTRICULAR LEAD HAD FRACTURED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED VARYING IMPEDANCES ON THIS RIGHT VENTRICULAR LEAD. IMPEDANCES RANGED FROM 1000 TO 1400 OHMS. THRESHOLDS HAD ALSO INCREASED SINCE IMPLANT. IN ADDITION, THE LEFT VENTRICULAR LEAD HAD BEEN PROGRAMMED OFF IN PREPARATION FOR A LEAD REVISION DUE TO GREATER THAN 2000 OHMS RECORDED BY THE DEVICE AND NORMAL OHMS THROUGH THE PACING SYSTEM ANALYZER. THE PHYSICIAN OBSERVED BLOOD IN THE LEFT VENTRICULAR PORT AFTER REMOVING THE PORT PLUG. THE BLOOD APPEARED TO HAVE PREVENTED THE LEAD FROM BEING FULLY INSERTED INTO THE PORT. INITIALLY THE BLOOD COULD NOT BE REMOVED. HOWEVER, ULTIMATELY THE BLOOD WAS CLEARED FROM THE PORT, THE LEFT VENTRICULAR LEAD WAS EXTRACTED AND A NEW LEAD SUCCESSFULLY IMPLANTED. IN ADDITION, IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD MIGHT HAVE BEEN DAMAGED DURING THE PROCEDURE AND THEREFORE IT WAS SURGICALLY ABANDONED AS THE COIL UNRAVELED. A NON-BOSTON SCIENTIFIC LEAD WAS SUCCESSFULLY IMPLANTED. THIS PATIENT'S POCKET WAS REPORTED TO HAVE BEEN REOPENED THREE TIMES SINCE THE INITIAL IMPLANT TO ADDRESS ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention RZ70TV| 0148| MISMATCH| 1861| H170| 4542| 4470| N119