BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2182684 · Received July 28, 2011

    Report

    Report Number
    2124215-2011-12737
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE. SINCE THE DEVICE WOULD HAVE HAD TO BE PROGRAMMED WITH MAXIMUM RV OUTPUTS IN ORDER TO MAINTAIN THE CORRECT SAFETY MARGIN, A LEAD REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization| L| R S603| S606| 1298| 4471| 4086| 4034