BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE

    MDR report key: 5124700 · Received October 11, 2004

    Report

    Report Number
    5124700
    Event Type
    Injury
    Date Received
    October 11, 2004
    Date of Event
    July 14, 2004
    Report Date
    October 11, 2004
    Manufacturer
    ST. JUDE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    VENTRICULAR LEAD 1028-T WAS IMPLANTED (B)(6) 1992 WITH DDD PACEMAKER. SUBSEQUENTLY, SHE HAS HAD NEW PACEMAKERS IMPLANTED DUE TO BATTERY DEPLETION. ON (B)(6) 1998 AND (B)(6) 2003. REVIEW OF RECORDS REVEALED VENTRICULAR LEAD DETERIORATED AS FOLLOWS: IMPEDANCES: (B)(6) 1998 = 630 OHMS; (B)(6) 2001 = 55 OHMS INCREASED; (B)(6) 2004 = 1280 OHMS. CAPTURE TRENDED ALSO DETERIORATED: (B)(6) 2001 = 3.5 VOLTS AT 1.0 MSEC; (B)(6) 2004 = GREATER THAN 7.5 VOLTS AT 3 MSEC. SENSING REMAINED STABLE GREATER THAN 10 MV. ON (B)(6) 2004, VENTRICULAR LEAD 1028-T WAS CAPPED OFF, NEW V. LEAD IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE VENTRICULAR LEAD DTB ST. JUDE 1028-T

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization