BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1953739 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24109
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSVENOUS DEFIBRILLATION LEAD, THE LEAD DID NOT SENSE OR CAPTURE PROPERLY IN AN IDEAL POSITION. A RIGHT VENTRICULAR (RV) PACING LEAD WAS PLACED TO CHECK SENSING IN THE RV. THEN ANOTHER DEFIBRILLATION LEAD WAS ATTEMPTED AND THE MEASUREMENTS WERE BETTER AND CAPTURED BUT THE PHYSICIAN FELT A DUAL COIL LEAD SHOULD BE IMPLANTED, WHICH WAS IMPLANTED WITH NO FURTHER ISSUES. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 316 MO (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)