BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 2936223 · Received January 30, 2013

    Report

    Report Number
    2124215-2013-02056
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 ROUTINE DEVICE CHANGE OUT PROCEDURE, THIS IMPLANTED RIGHT VENTRICULAR (RV) LEAD'S CONNECTOR PIN HAD SEPARATED FROM THE LEAD BODY DURING A TUG TEST WITH A NEWLY IMPLANTED DEVICE. THE LEAD WAS SURGICALLY CAPPED AND ABANDONED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40256 SWEET TIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4243

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR 1274| 1184| K062| 4243| 4244| 4087