BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1962300 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00994
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS ACTIVELY IMPLANTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS EXHBITING ELEVATED THRESHOLD MEASUREMENTS DUE TO SUSPECTED MICRODISLODGEMENT. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLLY REPOSITIONED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4543| H120| 4088| MISMATCH