BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2040060 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-01770
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 5, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO FURTHER INFORMATION HAS BEEN COMMUNICATED. IF NEW DEATILS ARE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CLINICAL FOLLOW-UP, LEAD IMPEDANCE VALUES WITH THIS PRODUCT WERE LESS THAN EXPECTED. THE PATIENT WAS INSTRUCTED TO RETURN AFTER TWO WEEKS, AT WHICH TIME LOSS OF CAPTURE WAS CONFIRMED. AN X-RAY FAILED TO SHOW CONDUCTOR DAMAGE; HOWEVER, THE PHYSICIAN ELECTED TO SCHEDULE A LEAD REVISION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN GUIDANT PUERTO RICO BV 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention