BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 4132359 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-16330
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED FOR AN UNKNOWN REASON. ATTEMPTS TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED AT THAT TIME. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612955 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R S602| 4087| 1688TC