BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARDIAL TINED LEAD

    MDR report key: 383611 · Received February 8, 2002

    Report

    Report Number
    2124215-2002-03756
    Event Type
    Malfunction
    Date Received
    February 8, 2002
    Date of Event
    November 6, 2001
    Report Date
    November 6, 2001
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED THESE LEADS RETURNED FOR ANALYSIS FOLLOWING THE DEATH OF THIS PATIENT. THERE IS NO CURRENT ALLEGATION INFORMATION. EVENTS HAVE BEEN PREVIOUSLY PROCESSED ON THREE OF THESE LEADS; 0030/022670 AND 0030/022603 WERE CAPPED IN JANUARY OF 1997 DUE TO INAPPROPRIATE SHOCKS DUE TO OVERSENSING. THESE LEADS WERE REMOVED FROM SERVICE AND REPLACED WITH 0012/200343. TWO YEARS LATER, IN SEPTEMBER OF 1999, THE 0012 LEAD WAS CAPPED DUE TO INAPPROPRIATE SHOCKS RELATED TO A POSSIBLE FRACTURE. ALL OF THE RETURNED LEADS WILL BE ANALYZED IN GUIDANT'S RELIABILITY LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCARDIAL TINED LEAD IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS 0012 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other THE DEVICE 0041/102590 WAS IMPLANTED 11-MAR-1988