BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1863742 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15909
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT REMAINS IN SERVICE, IT WILL NOT BE RETURNED FOR ANALYSIS AND BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE CLINICAL OBSERVATION. THERE IS NO ADDITIONAL INFORMATION RELATED TO THIS EVENT AVAILABLE, OR TO THE COMPANY AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SUCCESSFULLY REPOSITIONED DURING A REVISION PROCEDURE. THE REASON FOR THE PROCEDURE WAS A LOSS OF SENSING AMPLITUDE (12MV TO 2MV) DUE TO DISLODGEMENT. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention