BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 1952244 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23696
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LEAD SAFETY SWITCH (LSS) OCCURRED ON THIS RIGHT ATRIAL (RA) LEAD. THERE WAS NOISE ON THE LEAD WHICH WAS REPRODUCIBLE WITH ISOMETRICS BUT NOT WITH POCKET MANIPULATION. THIS LEAD HAS A HISTORY OF POOR SENSING. THRESHOLDS CANNOT BE CHECKED SINCE THE PATIENT IS IN ATRIAL FIBRILLATION. UNIPOLAR AND BIPOLAR IMPEDANCE MEASUREMENTS ARE CURRENTLY 760 OHMS. AT THE LAST CHECK, BIPOLAR IMPEDANCE WAS 710 OHMS. IMPEDANCE MEASUREMENTS FOR THE PAST SEVEN DAYS ARE LISTED AS 'N/R', EXCEPT FOR ONE DAY WHICH WAS 760 OHMS. THERE WAS NO EVIDENCE OF AN OUT OF RANGE IMPEDANCE MEASUREMENT. TECHNICAL SERVICES DISCUSSED WHAT WOULD CAUSE A LSS AND THAT THERE MAY BE NO INDICATION OF AN OUT OF RANGE IMPEDANCE MEASUREMENT WITH THE WEEKLY AVERAGE OF DAILY MEASUREMENTS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4063

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)