BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1853476 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14783
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    October 3, 2008
    Report Date
    November 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY FIFTEEN MONTHS LATER WE RECEIVED A LATITUDE RED ALERT FOR A HIGH OUT OF RANGE RV PACING IMPEDANCE GREATER THAN 2,000 OHMS. ADDITIONAL INFORMATION INDICATED NO INTERVENTION PLANNED TO BE PERFORMED. ALL OTHER MEASUREMENTS REMAINED WITHIN NORMAL RANGE.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE RV LEAD REMAINS IN SERVICE WITH THE NEW DEVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXHIBITING FLUCTUATING PACING IMPEDANCE MEASUREMENTS WHILE IT WAS IN SERVICE WITH PREVIOUS DEVICE. A DEVICE CHANGE-OUT PROCEDURE TOOK PLACE AND THE PACING IMPEDANCES INCREASED TO GREATER THAN 2000 OHMS WHEN CONNECTED TO THE NEW DEVICE. IT WAS VERIFIED ON X-RAY THAT THE HELIX ON THE RV LEAD WAS NOT DEPLOYED. THE PHYSICIAN ELECTED TO LEAVE THE LEAD IN SERVICE WITH THE NEW DEVICE AS THE OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE AND DEFIBRILLATION THRESHOLD TESTING (DFT) WAS SUCCESSFUL. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR H217| 5076| 4555| 0184