BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAMITRODE S-8 LEAD KIT, 60CM LENGTH

    MDR report key: 2602669 · Received May 31, 2012

    Report

    Report Number
    1627487-2012-05799
    Event Type
    Death
    Date Received
    May 31, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT#: 1627487-2012-05798. ON (B)(6) 2012, THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND TWO LEADS (FROM THE SAME LOT). AT THE END OF THE IMPLANT PROCEDURE, THE PT WAS NO LONGER BREATHING OR SHOWING SIGNS OF A HEARTBEAT. CPR WAS PERFORMED AND THE PT WAS RESUSCITATED. AFTERWARDS, THE PT WAS ADMITTED TO THE ICU. WHILE IN THE ICU, THE PT EXPERIENCED LUNG FAILURE AND WAS PLACED ON LIFE SUPPORT. ON (B)(6) 2012, THE PT WAS TAKEN OFF OF LIFE SUPPORT AND PASSED AWAY. ALLEGEDLY, THE DOCTOR DOES NOT BELIEVE THE EVENT WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S-8 LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3593586

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| L| R