BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1910245 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03293
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WAS IMPLANTED WITH PERCUTANEOUS LEADS ON (B)(6) 2007 FOR BACK AND BILATERAL HIP AND LEG PAIN. IT WAS REPORTED THAT FOLLOWING A RECENT FUSION PROCEDURE, SHE NO LONGER FELT STIMULATION. INSTEAD, SHE WAS EXPERIENCING A SHOCKING SENSATION THROUGHOUT HER BODY. AN X-RAY REVEALED THAT BOTH OF THE PATIENT'S LEADS HAD MIGRATED, WITH ONE COMPLETELY OUT OF THE EPIDURAL SPACE. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO REPOSITION THE LEADS; HOWEVER, A DATE FOR THE PROCEDURE HAS NOT BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3186 68484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention