BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 3052690 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04151
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 6, 2013
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    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 DURING A RECENT UPGRADE PROCEDURE, THIS LEAD WHICH HAD BEEN PREVIOUSLY REPAIRED, WAS REPAIRED AGAIN. THE PHYSICIAN ASKED IF THERE WAS SUPPOSED TO BE A SLIT IN THE SILICON TUBING THAT WRAPS AROUND THE DAMAGE ON THE LEAD INSIDE OF THE LEAD REPAIR KIT, BECAUSE THERE WAS NOT. MEDICAL ADHESIVE WAS USED AND THE LEAD REMAINS IN SERVICE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156966 SWEET TIP IMPLANTABLE LEAD NVN HISTORICAL CPI ST. PAUL 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 4269| 1298| 0940| K173