BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 2151721 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07976
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED. 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 DEVICE CHANGE OUT PROCEDURE, REMOVAL DIFFICULTY WAS EXPERIENCED WHILE ATTEMPTING TO EXPLANT THIS IMPLANTABLE DEFIBRILLATION LEAD WITH A LASER. THE LEAD BROKE OFF AND THE PHYSICIAN ELECTED TO LEAVE THE REMAINING PORTION OF THE LEAD IN THE PATIENT. AN INSULATION BREAK WAS ALSO NOTED ON THE LEAD DURING THE EXPLANT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN GUIDANT PUERTO RICO BV 0010

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR 6931| 5076| 1857| 1550| 0185| 0010| E102| 0041| E110| 0020| 1746| MISMATCH