BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 3904801 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09697
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED. 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 DURING A FOLLOW UP VISIT, INTERROGATION OF THIS ATRIAL LEAD REVEALED NOISE AND INCREASED THRESHOLD MEASUREMENTS. IN ADDITION, THE LEAD HAD SWITCHED TO UNIPOLAR PACING DUE TO OUT OF RANGE IMPEDANCE MEASUREMENTS. INTERMITTENT CAPTURE WAS OBSERVED AT 5V. THERE WAS CONCERN THIS LEAD MAY BE FRACTURED. THERE WERE NO PAUSES OR ASYSTOLE AS A RESULT OF THIS ISSUE AS THE PATIENT HAS AN UNDERLYING INTRINSIC CARDIAC RHYTHM. A DECISION WAS MADE TO REPROGRAM THE DEVICE TO VVIR PACING MODE AS THE PATIENT IS ELDERLY AND AN INTERVENTION IS NOT INTENDED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382296 SELUTE PICOTIP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 4064

    Patients

    Seq Age Sex Outcome Treatment
    1 4035| K183| 4064