BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 1951450 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22982
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACER DEPENDENT PATIENT PRESENTED WITH SYMPTOMS OF DIZZINESS AND LIGHTHEADED. A 12 LEAD ELECTROCARDIOGRAM SHOWED INTERMITTENT VENTRICULAR CAPTURE. THRESHOLDS WERE WIDELY FLUCTUATING FROM 1V TO 3V. NOISE AND OVERSENSING COULD NOT BE PRODUCED WITH ISOMETRICS OR POCKET MANIPULATION AND NOT OBSERVED ON STORED ELECTROGRAMS. THE VENTRICULAR OUTPUTS WERE INCREASED. THE PATIENT WAS UNDER 48 HOUR SUPERVISION AND DURING THAT TIME NO FURTHER LOSS OF CAPTURE OR PATIENT SYMPTOMS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR 1283| 4015| 1290| 4034