BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 1946153 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20314
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    HISTORICAL PUERTO RICO
    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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXPERIENCED INTERMITTENT LOSS OF CAPTURE. INTERROGATION WAS UNSUCCESSFUL INITIALLY DUE TO UTILIZING AN INCORRECT PROGRAMMER. UPON SUCCESSFUL INTERROGATION, NO SURFACE ELECTROGRAM WAS AVAILABLE. OVERSENSING AND LOSS OF CAPTURE WITH A NOTED PAUSE WAS CONFIRMED. THE PACEMAKER HAS BEEN IMPLANTED FOR 16 YEARS. REPROGRAMMING WAS IMPLEMENTED TO DECREASE SENSITIVITY AND INCREASE OUTPUT. CURRENTLY, ALL PRODUCTS REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4261

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR (B)(4)| (B)(4)