BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1870474 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-16828
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ASSOCIATED WITH A REMOTE MONITORING ALERT SENT TO THE PATIENT'S HEALTH CARE PROVIDER (HCP) FOR A HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENT 17.9 MONTHS AFTER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR 1688TC| N119| 4542| 0147