BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 4132212 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15670
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    March 19, 2014
    Report Date
    July 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WITH NON-BOSTON SCIENTIFIC DEVICE DISPLAYED DECREASED IMPEDANCE TRENDING. INSULATION DAMAGE WAS SUSPECTED. A FOLLOW UP IS INTENDED IN APPROXIMATELY THREE MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. BIPOLAR IMPEDANCE MEASUREMENTS WERE LOW OUT OF RANGE. ALL UNIPOLAR MEASUREMENTS WERE WITHIN ACCEPTABLE RANGE. AS IT WAS THOUGHT THERE WAS INSULATION DAMAGE, FLUOROSCOPY WAS PERFORMED REVEALING NO VISUAL ANOMALY. IN ADDITION, THE PATIENT WITH THIS LEAD EXPERIENCED PECTORAL STIMULATION WHICH WAS RESOLVED WITH REPROGRAMMING OUTPUT SETTINGS. ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IN SERVICE. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612555 SELUTE PICOTIP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 4064

    Patients

    Seq Age Sex Outcome Treatment
    1 4035| 4064| 5826