BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 88 LEAD KIT, 60CM LENGTH

    MDR report key: 2003865 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-00255
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    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

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2011 INCLUDING A SURGICAL LEAD. IT WAS REPORTED LATER THAT DAY THAT HER LEGS WERE WEAK, AND SHE WAS EXPERIENCING LEG PAIN. FOLLOW-UP ON THE PATIENT FOUND THAT SHE IS DOING WELL. HER SCS SYSTEM WAS RECENTLY REPROGRAMMED, AND SHE IS RECEIVING ADEQUATE THERAPY COVERAGE. THE REPORTED LEG PAIN HAS SUBSIDED, AND THERE ARE NO FURTHER ISSUES OF CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88 LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3288 2935476

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention