BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2060010 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05710
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 31, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. 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 UPON ROUTINE CHECK ONE DAY POST IMPLANT OF THIS RIGHT VENTRICULAR (RV) LEAD, TWO OR THREE EVENTS OF VENTRICULAR TACHYCARDIA (VT) LASTING SEVEN OR EIGHT BEATS WERE OBSERVED. AN XRAY CONFIRMED THAT THE LEAD HAD DISLODGED INTO THE APEX. SENSING HAD DECREASED, HOWEVER, CAPTURED REMAINED AVAILABLE. A LEAD REVISION PROCEDURE WAS SUCCESSFULLY PERFORMED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R