BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210212 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07959
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 THE PATIENT WITH THIS RV LEAD UNDERWENT A CHANGE-OUT PROCEDURE. THIS RV LEAD'S RATE/SENSE PORTION AND THE RIGHT ATRIAL (RA) LEAD WERE STUCK IN THE HEADER AND SET SCREWS OF THE OLD DEVICE. ATTEMPTS WERE MADE TO FREE THE LEADS, BUT THEY WERE UNSUCCESSFUL AND THE PHYSICIAN CUT THE RV LEAD'S RATE/SENSE PORTION AND RA LEAD AND SURGICALLY ABANDONED THEM. THE DEVICE WAS THEN EXPLANTED. A NEW DUAL CHAMBER ICD WAS IMPLANTED, AND THE RV HIGH VOLTAGE PORTION REMAINS IN SERVICE AND THE RA PORT WAS PLUGGED. THE PATIENT'S CHRONIC LEFT VENTRICULAR (LV) LEAD WAS BEING USED AS THE RATE/SENSE LEAD IN THE RV RATE/SENSE PORT OF THE NEW DEVICE. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS DONE AND SUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311429 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR H170| 0184| 4047| 4517| 4469| E163