BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3110691 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-10145
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 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
    BE
    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

    IT WAS REPORTED, THE PATIENT ((B)(6)) DID NOT HAVE EFFECTIVE STIMULATION IN THE NEEDED AREAS. DIAGNOSTIC TESTING IDENTIFIED INVALID IMPEDANCES. THE PHYSICIAN ELECTED TO EXPLANT THE SCS LEAD. AN ADDITIONAL SURGERY WAS PERFORMED AT A LATER DATE TO REPLACE THE SCS LEAD. EFFECTIVE STIMULATION WAS RESTORED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208042 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3697132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention