BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2162516 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-08009
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC'S TECHNICAL SERVICE CONSULTANT ADVISED PROGRAMMING THE RIGHT VENTRICULAR SENSING RATE TO 5MV RATHER THAN 2.5MV. THE SYSTEM REMAINS IMPLANTED. IF FURTHER INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR EXPERIENCED A SINGLE EPISODE OF ATRIAL TACHYCARDIA RESPONSE DUE TO NOISE ON BOTH CHANNELS. THE PATIENT BECAME DIZZY AS THERAPY WAS INHIBITED FOR GREATER THAN TWO SECONDS.

    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 79 YR Life Threatening| R 1274| 4244| 4035| 1290