BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE TRAIL LEAD KIT, 60CM LENGTH

    MDR report key: 2080425 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-00543
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT TESTING WAS NOT PERFORMED AS THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED THROUGH SUCH MEANS. 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 AN SCS TRIAL SYSTEM FOR LOW BACK AND BUTTOCK PAIN ON (B)(6) 2011 INCLUDING A PERCUTANEOUS LEAD. IT WAS REPORTED THAT THE LEAD MIGRATED IMMEDIATELY AFTER THE IMPLANT PROCEDURE RESULTING IN THE LOSS OF STIMULATION FOR THE PATIENT. THE LEAD WAS REPOSITIONED; HOWEVER, MIGRATION ALLEGEDLY OCCURRED AGAIN. THE PHYSICIAN REPLACED THE DEVICE, AND STIMULATION WAS CAPTURED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE TRAIL LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3086 3254415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention