BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1951447 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22905
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE AND VENTRICULAR LEAD REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SALES REPRESENTATIVE (SR) WAS CONCERNED WITH POSSIBLE UNDERSENSING WITH THIS DEVICE. TECHNICAL SERVICES (TS) REVIEWED SOME STRIPS THE SR FAXED IN AND DISCUSSED POTENTIAL VENTRICULAR LOSS OF CAPTURE. LEAD MEASUREMENTS ARE STABLE AND NO PATIENT SYMPTOMS WERE REPORTED. TS RECOMMENDED TRYING TO RECREATE NOISE AND TO CONTINUE MONITORING PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR (B)(4)| (B)(4)| (B)(4)