BEUDAMED
    FDA Adverse Event Death Summary report: N

    EASYTRAK 2

    MDR report key: 3240211 · Received July 22, 2013

    Report

    Report Number
    2124215-2013-11700
    Event Type
    Death
    Date Received
    July 22, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 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

    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 FOLLOWING IMPLANT/PLACEMENT OF THIS LEFT VENTRICULAR(LV) LEAD, THE PATIENT ARRESTED. EXTERNAL DEFIBRILLATION WAS PERFORMED WHICH SUCCESSFULLY RESTORED THE PATIENT TO A NORMAL RATE; HOWEVER, INTERFERED WITH PRODUCT STERILITY. AS A RESULT, THE LEAD WAS EXPLANTED. THE PHYSICIAN THEN ELECTED TO UPGRADE THE IMPLANT FROM A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTED ALL NEW LEADS. FOLLOWING THE SECOND SYSTEM IMPLANT, THE PATIENT AGAIN ARRESTED; HOWEVER, THE PHYSICIAN WAS UNABLE TO RESTORE A NORMAL RHYTHM AND THE PATIENT PASSED AWAY. THE ELDERLY PATIENT HAD BEEN REPORTED IN ILL HEALTH PRIOR TO THE ATTEMPTED IMPLANT AND NO RETURN OF PRODUCT IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339640 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R