BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 2161568 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-06994
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 15, 2011
    Report Date
    November 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED DUE TO NOISE WHICH LEAD TO 1.5 SECONDS OF PACING INHIBITION. THE RATE SENSE PORTION OF THE LEAD WAS ABANDONED AND A NEW LEAD WAS PLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT INTERROGATION OF THIS DEVICE A CHECK RIGHT ATRIAL (RA) LEAD SCREEN SHOWED UP. THE RA LEAD AMPLITUDE HAS INCREASED SINCE IMPLANT, THE THRESHOLDS IN THE ATRIUM ARE BEING OVERSENSED IN THE VENTRICLE CAUSING PACING INHIBITION. AS A RESULT THE PROGRAMMED SETTINGS FOR SENSING WILL BE OPTIMIZED WHICH WILL ALLEVIATE THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4245

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 1831| 4244| 0145| E110| A155| 4245