BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3040662 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00172
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE RIGHT VENTRICULAR (RV) LEAD HAD TRIPPED THE LEAD SAFETY SWITCH DUE TO IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. WHILE INVESTIGATING, IT WAS NOTED THAT VENTRICULAR TACHYCARDIA (VT) EPISODES WERE STORED DUE TO NOISE. WHEN TELEMETRY WAS REMOVED, THE NOISE PERSISTED; HOWEVER, ONLY OCCURED IN BIPOLAR CONFIGURATION. THE PATIENT WAS NOT PACEMAKER DEPENDENT AND HAD NO SYMPTOMS. WHEN THE MINUTE VENTILATION WAS PROGRAMMED OFF, THE NOISE RESOLVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT TH POCKET WAS OPENED AND VISUAL CHECK OF THE LEAD CONFIRMED THAT THE LEAD WAS FULLY INSERTED INTO THE DEVICE. UPON REMOVAL OF THE LEAD FROM THE HEADER, DRIED BLOOD WAS NOTED ON BOTH THE TERMINAL PIN AND RING ELECTRODE AS WELL AS IN THE RV PORT. THE LEAD WAS THOROUGHLY CLEANED AND THE PORT WAS FLUSHED. ALL TESTING CONFIRMED NORMAL FUNCTION. THE SYSTEM REMAINS IMPLANTED AS THE PHYSICIAN BELIEVED THE CLINICAL OBSERVATIONS WERE A RESULT OF THE BLOOD INFILTRATION, WHICH WAS REMOVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142774 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention