BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 3052641 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03955
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT PLANNED TO RETURN HOME WITHIN TWO WEEKS, WHERE HIS PHYSICIAN WOULD DETERMINE ANY NEXT STEPS IN THE PATIENT'S CARE. THE LEAD REMAINS IN SERVICE WITH NO SURGICAL INTERVENTION PERFORMED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS LEFT VENTRICULAR (LV) LEAD AND ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS HOSPITALIZED WHILE TRAVELING. THE CAUSE OF THE PATIENT'S HOSPITALIZATION WAS NOT KNOWN. THE PHYSICIAN WAS ABLE TO CONFIRM THE DEVICE WAS PROVIDING BI-VENTRICULAR PACING AND THE DEVICE MAGNET RATE WAS 100 PPM. A PROGRAMMER WITH THE CORRECT SOFTWARE FOR THE PATIENT'S DEVICE WAS SENT TO THE HOSPITAL. UPON INTERROGATION, INTERMITTENT LOSS OF CAPTURE IN THE LV WAS OBSERVED, AND THE LV PACING THRESHOLD MEASUREMENTS HAD INCREASED. THE LV PACING OUTPUTS WERE INCREASED AND CONSISTENT CAPTURE WAS OBTAINED. RIGHT VENTRICULAR PACING REMAINED AVAILABLE. AN X-RAY WAS PERFORMED AND SHARED WITH THE PATIENT'S IMPLANTING PHYSICIAN; THE IMPLANTING PHYSICIAN BELIEVED THE LEAD TO BE IN THE SAME POSITION AS AT THE LAST DEVICE CHECK. HOWEVER, BASED ON THE RESULTS OF THE DEVICE INTERROGATION, THE PHYSICIAN TREATING THE PATIENT IN THE HOSPITAL SUSPECTED THE LV LEAD WAS DISLODGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154513 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4548

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 5076| H140| 4548