BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 2922007 · Received January 4, 2013

    Report

    Report Number
    1627487-2013-02022
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    IT WAS REPORTED THE PATIENT LOST EFFECTIVE STIMULATION COVERAGE IN HER FOOT. DIAGNOSTIC TESTING REVEALED NO ANOMALIES AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. IT WAS REPORTED THE PHYSICIAN PLANS TO REVISE THE LEAD'S PLACEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5973 LAMITRODE 44 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3244 114844

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS EXTENSION: MODEL 3383| SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE: