BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 3070425 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06541
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    May 25, 2010
    Report Date
    March 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO OUR RESOURCES, THE LEAD REMAINS IN SERVICE AT THIS TIME. 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, MYOPOTENTIAL OVERSENSING AND OUT OF RANGE IMPEDANCE MEASUREMENTS WHICH TRIGGERED THE LEAD SAFETY SWITCH (LSS) ON THE ASSOCIATED DEVICE. LEAD TESTING DURING ISOMETRICS AND POCKET MANIPULATIONS, NOTED AN IMPEDANCE MEASUREMENT OF 280 OHMS. INSULATION DAMAGE WAS SUSPECTED. THE PATIENT ONLY PACES 2-3% IN THE ATRIUM AND THE ASSOCIATED DEVICE HAD ONE YEAR OF DEVICE LONGEVITY. THEREFORE, THE LEAD WAS REPROGRAMMED TO BIPOLAR CONFIGURATION AND REMAINED IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED STATING THIS LEAD IS NOW GOING TO BE REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171318 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4064

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 4035| 4064| 1280