BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 3161455 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-02787
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    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 WAS NOT GETTING ADEQUATE STIMULATION COVERAGE. SHE STATED SHE WAS GETTING STIMULATION IN AREAS WHERE SHE DOES NOT NEED IT. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248928 LAMITRODE TRIPOLE 16C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3214 96475

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS IPG: MODEL 3716| IMPLANT DATE: