BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 2400842 · Received January 2, 2012

    Report

    Report Number
    MW5023688
    Event Type
    Injury
    Date Received
    January 2, 2012
    Date of Event
    September 13, 2011
    Report Date
    January 2, 2012
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS SHOCKED TWICE FOR NOISE ON RV LEAD. HV LEAD IMPEDANCE WAS NOTED TO BE 19 OHMS. TECHNICAL SUPPORT AT SJM ADVISED MAY BE POSSIBLE INNER INSULATION BREACH. PT WAS ADMITTED. DATES OF USE: (B)(6) 2002 - (B)(6) 2011. REASON FOR USE: VENTRICULAR TACHYCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL RIATA LWS ST JUDE MEDICAL 1581

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization