BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040692 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00788
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE PRODUCT REMAINS IMPLANTED AND IN SERVICE WITHOUT FURTHER REPORTED COMPLICATIONS. IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOUR DAYS POST IMPLANT, A DECREASE IN RIGHT VENTRICULAR SENSING WAS EXHIBITED; LEAD CONFIRMED DISLODGED. THE PHYSICIAN ELECTED TO PERFORM A LEAD REVISION, AT WHICH TIME THE PRODUCT WAS SUCCESSFULLY REPOSITIONED. NO SPECIFIC ADVERSE EFFECTS 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