BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1871922 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17446
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED AND WAS UNABLE TO BE REPOSITIONED DUE TO TISSUE ON HELIX. A NEW RA LEAD WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE HOSPITAL RETAINED THE ORIGINAL RA LEAD, SO THEREFORE IT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L| R 4086| S603| 4456