BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3052801 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05544
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE FIELD REPRESENTATIVE WAS UNABLE TO FIND OUT ANY ADDITIONAL INFORMATION FROM THE CLINIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ALONG WITH ELEVATED THRESHOLD MEASUREMENTS. THE CLINICIAN NOTED THAT A REVISION PROCEDURE WOULD BE SCHEDULED. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDTIIONAL INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156550 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 4087| 0185| E030