BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE

    MDR report key: 2173300 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11613
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 DURING A REPLACEMENT PROCEDURE, IT WAS NOTED THAT THE LEADS COULD NOT BE REMOVED FROM THE HEADER'S LEAD PORTS. MINERAL OIL WAS APPLIED TO THE SET SCREWS, BUT THE LEAD STILL COULD NOT BE REMOVED. BONE CUTTERS WERE THEN USED TO CLIP AWAY THE BACK END OF THE HEADER TO EXPOSE THE LEAD PORT AND A TORQUE WRENCH WAS USED TO PUSH THE LEAD OUT OF THE HEADER. THE LEAD WAS THEN SUCCESSFULLY CONNECTED TO THE NEW DEVICE. TESTING OF THE LEAD CONFIRMED THAT ALL MEASUREMENTS WERE WITHIN NORMAL RANGE WHEN THE PROCEDURE WAS COMPLETED. THE DEVICE HAS BEEN DISPOSED OF AS IT WAS IN PIECES WHEN IT WAS REMOVED. IT WILL THEREFORE NOT BE RETURNED FOR INVESTIGATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE IMPLANTABLE LEAD NVN GUIDANT PUERTO RICO BV 4285

    Patients

    Seq Age Sex Outcome Treatment
    1