BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2052611 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03924
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE WITH INCREASED PACING OUTPUTS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, 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 PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF DIZZINESS AND SYNCOPE. IT WAS DETERMINED THAT THE RIGHT VENTRICULAR LEAD WAS NOT CAPTURING DUE TO ELEVATED THRESHOLD MEASUREMENTS. THE SALES REPRESENTATIVE INCREASED PACING OUTPUTS AND NOTED THE NEXT STEP WOULD BE DOING BLOOD WORK TO TRY AND UNDERSTAND THE PATIENT'S ELECTROLYTES. IT WAS NOTED THAT THE INCREASE IN THRESHOLDS MAY BE DUE TO THE PATIENT'S CHEMISTRIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4035

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| L 1276| 4035| S403| 1290| 4269