BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1893029 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-03120
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 RECEIVED HER SCS SYSTEM ON (B)(6) 2005. IT WAS REPORTED THAT SHE GRADUALLY LOST STIMULATION. THE PT'S INTENDED AREA OF COVERAGE WAS HER BACK; HOWEVER, OVER TIME THE STIMULATION MOVED TO HER BUTTOCKS. REPROGRAMMING ATTEMPTS TO RECAPTURE EFFECTIVE THERAPY PROVED UNSUCCESSFUL. X-RAYS WERE TAKEN WHICH REVEALED THAT THE PT'S LEADS HAD MIGRATED. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO REPLACE 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 34721

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention