BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE MEDICAL

    MDR report key: 1658759 · Received April 9, 2010

    Report

    Report Number
    MW5015522
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 9, 2010
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ST JUDE MEDICAL ICD MODEL CD2211-36Q PROMOTE + RF 36 W/SJ4 CONNECTOR- (B) (4), STUDY START DATE: (B) (6) 2009; ESTIMATED STUDY COMPLETION DATE: (B) (6) 2016- (B) (4), MODEL 1888TC/46; TENDRIL (B) (4), AND MODEL 7120Q/52; DURATA SJ4 -CLINICAL POST TRIAL (B) (4) WERE IMPLANTED VIA CARDIOLOGIST, (B) (6) ON (B) (6) 2010. CARDIAC ELECTROPHYSIOLOGY MD, (B) (6) TESTED THE EQUIPMENT ON (B) (6) 2010 IN THE AM, BOTH DOCTORS LOCATED AT (B) (6). THE OUTCOME WAS IMMEDIATE DEATH. AFTER THE TESTING, THE PT STOPPED BREATHING BUT WAS TALKING, MAKING JOKES DOING WELL PRIOR TO THE AM TESTING AND WAS ABOUT TO BE RELEASED FROM THE HOSPITAL. MEDICAL DEVICE IS STILL IN POST CLINICAL TRIALS AND IT IS NOT KNOWN IF THE PT WAS ADVISED OF THOSE TRIALS BEFORE THE DEVICE AND LEADS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL ICD LWS ST JUDE MEDICAL CD2211-36Q
    2 TENDRIL ST OPTIM NONE LWS ST. JUDE MEDICAL 1888TC/46
    3 DURATA SJ4 NONE LWS ST. JUDE MEDICAL 7120Q/52

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death