BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE S8

    MDR report key: 3010812 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-02383
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PATIENT UNDERWENT SURGERY FOR A PERMANENT SCS SYSTEM. IT WAS REPORTED INTRAOPERATIVE TESTING REVEALED INVALID IMPEDANCE READINGS ON ALL LEAD CONTACTS AFTER THE LEAD WAS IMPLANTED. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE; THEREFORE, THE PHYSICIAN REMOVED AND REPLACED THE LEAD. THE PATIENT REPORTED EFFECTIVE STIMULATION WITH THE SECOND LEAD AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108558 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3286 3804010

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788