BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3012215 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-10089
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT ((B)(6)) WAS NO LONGER RECEIVING EFFECTIVE STIMULATION. DIAGNOSTIC TESTING IDENTIFIED HIGH IMPEDANCE VALUES ON ALL OF THE SCS LEAD ELECTRODES. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104482 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3162647

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention