BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET PICOTIP

    MDR report key: 1951392 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22790
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICE WAS REPROGRAMMED. AT THIS TIME, THIS RA LEAD REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AND THERE WERE NO REPORTS THAT A REVISION WAS TO BE PERFORMED IN THE FUTURE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, THIS RIGHT ATRIAL (RA) LEAD PRESENTED WITH PACING IMPEDANCE MEASUREMENTS ABOVE 3,000 OHMS. IN ADDITION, NO CAPTURE WAS OBSERVED AT MAXIMUM OUTPUTS AND THERE WAS NOISE ON THE ELECTROCARDIOGRAMS. A LEAD FRACTURE WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other