BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE TRIAL LEAD KIT, 60CM LENGTH

    MDR report key: 2000760 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-00231
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: - REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. AS RECEIVED THE LEAD WAS OBSERVED TO HAVE COMPRESSION DAMAGE AND ADHESIVE RESIDUE ATTACHED. IT WAS DETERMINED THAT THE COMPRESSION DAMAGE TO THE OUTER TUBING WAS CAUSED BY THE SWIFT LOCK ANCHORS, AND THE ADHESIVE RESIDUE AND THE LABEL RESIDUE WERE FROM THE TRIAL. THE RETURNED DEVICE PASSED ALL FUNCTIONAL TESTING. 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

    DEVICE 1 OF 3. REFERENCE MFR. REPORT #S 1627487-2011-00232 AND 1627487-2011-00233. THE PT RECEIVED AN SCS TRIAL SYSTEM ON (B)(6) 2011 CONSISTING OF TWO PERCUTANEOUS LEADS AND A TRIAL STIMULATOR. ON (B)(6) 2011, IT WAS REPORTED THAT HE EXPERIENCED OVERSTIMULATION THROUGHOUT HIS ENTIRE BODY. THE ALLEGED INCIDENT CAUSED THE PT TO FALL AND LOSE CONSCIOUSNESS FOR A BRIEF PERIOD OF TIME. IT WAS ALSO REPORTED THAT THE PT EXPERIENCED NUMBNESS IN HIS LEFT ARM AND WAS UNABLE TO FEEL HIS FINGERS. A NEUROLOGICAL EXAM WAS PERFORMED BY THE IMPLANTING PHYSICIAN; HOWEVER, NO PROBLEMS WERE OBSERVED. THE PT'S TRIAL SCS SYSTEM WAS EXPLANTED, AND THE DEVICES IN QUESTION WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE EVALUATION FOR THE TRIAL STIMULATOR IS STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE TRIAL LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3086 321360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention