BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1953568 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23756
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS LEAD WILL BE RETURNED NO ANALYSIS WILL BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS PI WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A DECREASE WAS NOTED IN THE INTRINSIC R-WAVE AMPLITUDES ON THE ELECTROCARDIOGRAM. A LEAD DISLODGMENT WAS SUSPECTED. THE PHYSICIAN REPLACED THIS RV LEAD WITH A NEW LEAD. THE EXPLANTED LEAD WILL NOT BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1