BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 88 LEAD, 60CM LENGTH

    MDR report key: 2091638 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-00578
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    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

    THE PT REC'D AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011 FOR BACK AND BILATERAL LEG PAIN. IT WAS REPORTED THAT THE PT COULD BARELY WALK. SURGICAL INTERVENTION HAS BEEN SCHEDULED TO REPLACE THE PT'S LEAD. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88 LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3288 2898517

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788