BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 2910862 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15915
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    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

    NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING NOISE, LOW P-WAVE MEASUREMENTS AND LOW IMPEDANCE MEASUREMENTS WHICH HAD TRIGGERED THE LEAD SAFETY SWITCH (LSS) ON THE ASSOCIATED DEVICE. BIPOLAR IMPEDANCE IS 250 OHMS AND HAD BEEN DECREASING OVER THE PAST YEAR. THE DEVICE WAS REPROGRAMMED TO VVI MODE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18423 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4064

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR S603| 4064| 4285| 1290| 1270| 4088