BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2041055 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00763
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RA LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING THE IMPLANT PROCEDURE OF THE ASSOCIATED PG, DIFFICULTY WAS EXPERIENCED REPOSITIONING THIS RIGHT ATRIAL (RA) LEAD TO OBTAIN GOOD THRESHOLD MEASUREMENTS. ONCE LEADS WERE CONNECTED TO THE DEVICE, TESTING WAS COMPLETED, AND THE RESULTS INDICATED THERE WAS A MICRODISLODGEMENT. THE THRESHOLD WAS REPORTED AS BEING 2.7 VOLTS. THE PHYSICIAN ELECTED TO CLOSE THE POCKET, AND FOLLOW THE LEAD THRESHOLD MEASUREMENTS OVER THE NEXT FEW DAYS. A REPOSITIONING PROCEDURE MAY BE PERFORMED WITHIN THE NEAR FUTURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1