BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE

    MDR report key: 1050162 · Received May 14, 2008

    Report

    Report Number
    1050162
    Event Type
    Injury
    Date Received
    May 14, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ST. JUDE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OPTIMIZER DEVICE INTERROGATED AND FOUND TO HAVE HIGH IMPEDANCE SO SUSPECTED FRACTURE RV LEAD. DECISION MADE TO EXCHANGE DEFECTIVE LEAD. THIS WAS CARRIED OUT SUCCESSFULLY IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE PACER LEAD DTB ST. JUDE 1688T *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention