BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE

    MDR report key: 383509 · Received February 8, 2002

    Report

    Report Number
    2124215-2002-03861
    Event Type
    Malfunction
    Date Received
    February 8, 2002
    Date of Event
    December 10, 2001
    Report Date
    December 10, 2001
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT BOTH OF THESE FINELINE LEADS HAD SUSTAINED FRACTURES DUE TO CLAVICULAR/FIRST RIB ENTRAPMENT. THE LEADS WERE REMOVED FROM SERVICE AND SURGICALLY ABANDONED. ADDITIONAL GUIDANT LEADS WERE SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS 4460 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other THE DEVICE 4034/302611 WAS IMPLANTED 10-DEC-2001| THE DEVICE 1283/622086 WAS IMPLANTED 10-DEC-2001| THE DEVICE 4016/BIR238 WAS IMPLANTED 10-DEC-2001| THE DEVICE 1276/408639 WAS IMPLANTED 07-MAR-2000| THE DEVICE 4461/200118 WAS IMPLANTED 07-MAR-2000