BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL SUTURELESS PERMANENT PACING LEAD

    MDR report key: 383744 · Received March 22, 2002

    Report

    Report Number
    2182269-2002-00038
    Event Type
    Injury
    Date Received
    March 22, 2002
    Date of Event
    January 25, 1997
    Report Date
    March 22, 2002
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIV., INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED TO SJM BY GUIDANT CORP FOLLOWING THE REMOVAL OF THE LEAD. THIS PERMANENT PACING LEAD WAS IMPLANTED IN 1988 AND IN 1997 IT WAS CAPPED AND REMOVED FROM SVC DUE TO INAPPROPRIATE SHOCKS FROM OVER SENSING. FOLLOWING THE DEATH OF THE PT IN 2001, THE LEAD WAS RETURNED TO GUIDANT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOCARDIAL SUTURELESS PERMANENT PACING LEAD PERMANENT PACING LEAD DTB ST. JUDE MEDICAL, DAIG DIV., INC. 501170 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death PERMANENT PACING LEAD 0030.