BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE MEDICAL

    MDR report key: 2617698 · Received June 11, 2012

    Report

    Report Number
    MW5025780
    Event Type
    Death
    Date Received
    June 11, 2012
    Date of Event
    April 12, 2012
    Report Date
    June 11, 2012
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS FOUND DEAD IN HOME BY NEIGHBOR. EVENT PRIMARY REPORTED TO USER FACILITY (B)(4) 2012, BY PRIMARY CARE PHYSICIAN. BODY WAS SENT TO COUNTY MEDICAL EXAMINER'S OFFICE FOR AUTOPSY. MEDICAL EXAMINER'S OFFICE CONTACTED BY THIS OFFICE IMMEDIATELY AND WE WERE INFORMED THAT DEVICE WAS EXPLANTED, LEAD HAD BEEN CUT, ICD HAD NOT BEEN DEACTIVATED AND RESIDUAL SYSTEM HAD ALREADY BEEN SENT TO ANOTHER INSTITUTION FOR ANALYSIS. MFG COMPANY NOTIFIED IMMEDIATELY. COMPANY REP ASSISTED WITH CONTACTING OUTSIDE INSTITUTION TO FIND DEVICE. HAVE COMMUNICATED WITH MFG OF BIOMEDICAL DEPT OF OUTSIDE INSTITUTION, ICD HAS BEEN ACCEPTED BY THEM AND DEVICE IS TO BE ALREADY INTERROGATED BY ST JUDE REP AND THEN WILL BE SENT TO ST JUDE FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death IMPLANT DATE:| ST JUDE DEFIBRILLATOR, (B)(4) VR CURRENT,| SN: (B)(4)