BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 2792235 · Received October 10, 2012

    Report

    Report Number
    1627487-2012-01831
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-01830. IT WAS REPORTED, THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION IN HER KNEES. AN SJM REPRESENTATIVE MET WITH THE PATIENT MULTIPLE TIMES IN 2010 AND REPROGRAMMING WAS ABLE TO PROVIDE GOOD COVERAGE OF HER BACK AND LEGS TO RIGHT ABOVE THE KNEES. THE PATIENT HAS NOT USED OR CHARGED HER IPG IN OVER A YEAR. SHE IS SEEKING A SECOND OPINION, AND DOES NOT KNOW IF SHE WANTS A REVISION OF THE LEAD AND A REPLACEMENT OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3214 3066181

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention