BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3324152 · Received August 29, 2013

    Report

    Report Number
    1627487-2013-16287
    Event Type
    Injury
    Date Received
    August 29, 2013
    Date of Event
    August 7, 2013
    Report Date
    August 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PT COMPLAINED OF INEFFECTIVE STIMULATION COVERAGE, AND THIS THERAPY WAS VERY POSITIONAL. THE PT ALLEGEDLY HAS BEEN REPROGRAMMED NUMEROUS TIMES WITHOUT SUCCESS. X-RAYS AND DIAGNOSTIC TESTING REVEALED NO ANOMALIES. THE PT STATED HE IS UNSURE OF THE NEXT STEP AS HE IS UNABLE TO PROCEED WITH SURGICAL INTERVENTION DUE TO FINANCIAL CONSTRAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425100 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 2796137

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other IMPLANT DATE:| SCS EXTENSION, MODEL 3383 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788