BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8 SURGICAL LEAD

    MDR report key: 2023353 · Received March 16, 2011

    Report

    Report Number
    1627487-2011-02300
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    THE PATIENT ((B)(6)) RECEIVED AN SCS SYSTEM WHICH INCLUDED A SURGICAL LEAD. IT WAS REPORTED THE PATIENT SUDDENLY LOST STIMULATION. DIAGNOSTIC TESTING OF THE LEAD FOUND FIVE INVALID CONTACTS. THE LEAD WAS EXPLANTED. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN NOTED THE LEAD WAS "DAMAGED" BEHIND THE DISTAL END OF THE ANCHOR. THE EXPLANTED LEAD WAS REPLACED AND STIMULATION WAS RESTORED. THE IMPLANT DATE OF THE LEAD WAS NOT PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3286 3136803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention