BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 2051799 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04510
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    November 22, 2010
    Report Date
    February 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING NOISE AND IMPEDANCE MEASUREMENTS LESS THAN 100 OHMS. THE DEVICE SENSITIVITY WAS REPROGRAMMED FROM .75MV TO 1.0MV. THE PATIENT STATED SHE SOMETIMES FEELS LIGHTHEADED. THREE MONTHS LATER, THE PATIENT REPORTED THE LEAD IS FRACTURED AND STATED SHE HAS NO MONEY FOR A REPLACEMENT. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4271

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)