BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 6686428 · Received June 30, 2017

    Report

    Report Number
    MW5070788
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    May 17, 2016
    Report Date
    June 30, 2017
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSPITALIZATION FOR CAPPING OF CHRONIC RV LEAD DUE TO HIGH DEFIB THRESHOLDS, REMOVAL OF "Y" IVC COIL AND INSERTION OF NEW RV LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460685 ST. JUDE MEDICAL ICD LEAD LWS ST. JUDE MEDICAL 1580 RIATA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention