BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1945674 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20058
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 9, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REAPPORTIONING OF THIS RIGHT VENTRICULAR (RV) LEAD TOOK PLACE DUE TO HIGH THRESHOLDS, UNDERSENSING AS WELL AS A SUSPECTED PERFORATION. THE LEAD WAS SUCCESSFULLY REPOSITIONED WITH 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