BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE (II STEROX)

    MDR report key: 5409949 · Received February 18, 2004

    Report

    Report Number
    2124215-2003-00003
    Event Type
    Injury
    Date Received
    February 18, 2004
    Date of Event
    October 1, 2003
    Report Date
    December 1, 2003
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. EVENT CONCLUSION: DURING PACER VENTRICULAR LEAD EXTRACTION FROM PATIENT, 2-3MM SECTION OF LEAD TIP REMAINED IN THE PATIENT'S BODY. ATTEMPTS MADE TO RETRIEVE THE PIECE WITH BLUNT INSTRUMENTS (UNSUCCESSFUL) PHYSICIAN ATTEMPTED SNARE RETRIEVAL, BUT UNABLE TO RETRIEVE RELATED TO POSITION. SECOND PHY CALLED FOR 2ND OPINION. DECISION WAS MADE TO LEAD PIECE IN PATIENT'S BODY. GUIDANT REP PRESENT FOR CASE. DEVICE USAGE PROBLEM DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING. AT THIS TIME THE PHYSICIAN OPTED TO LEAVE THE PIECE OF THE LEAD IN THE PATIENT'S BODY. AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED, AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF THE PRODUCT IS RETURNED, OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE (II STEROX) VENTRICULAR LEAD DTB

    Patients

    Seq Age Sex Outcome Treatment
    1