BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 2403643 · Received January 3, 2012

    Report

    Report Number
    MW5023714
    Event Type
    Injury
    Date Received
    January 3, 2012
    Date of Event
    October 14, 2011
    Report Date
    January 3, 2012
    Manufacturer
    ST. JUDE MEDICAL S.C., INC. - US DIVISION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS IS THE MOST RECENT EVENT OF THIS RV LEAD WITH T-WAVE OVERSENSING. THERE WERE OTHER EPISODES DATED: (B)(6) 2011, (B)(6) 2010, (B)(6) 2009. THESE EPISODES SINCE SJ PG CHANGED OUT FOR MEDTRONIC. DURING THE (B)(6) 2009 OVERSENSING ISSUE THE SENSITIVITY WAS DECREASED FROM 0.3MV TO 0.6MV, WHICH WAS ALSO PROGRAMMED WHEN SHE HAD THE SJ PG. WITH THE SJ DEVICE SHE RECEIVED INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING ON THIS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL RIATA LWS ST. JUDE MEDICAL S.C., INC. - US DIVISION 1580

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability