BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 1864236 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16194
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS RA LEAD REMAINS ACTIVELY IN SERVICE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD HAD EXHIBITED LOSS OF CAPTURE AND OUT-OF-RANGE PACE IMPEDANCE MEASUREMENT EXCEEDING 2,000 OHMS. THE PATIENT HAD BEEN IN A CAR ACCIDENT TWO WEEKS PRIOR. THERE WAS NO ALLEGATION OF A CONNECTION ISSUE. A LEAD FRACTURE WAS NOT RULED OUT AT THE TIME OF THIS REPORT. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR MORE INFORMATION. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR E110| 4086| 0184