BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1904304 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02139
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 4. 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. ANS 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 4. REFER TO MANUFACTURER REPORT#S 1627487-2010-02141, 1627487-2010-02140, AND 1627487-2010-02142. THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2008, INCLUDING 3 LEADS, A DUAL EXTENSION AND AN IPG. IT WAS REPORTED ON (B)(6) 2008 THAT THE PATIENT FELL AND 3-4 DAYS LATER LOST STIMULATION. THE PATIENT WAS SENT FOR X-RAYS. ON (B)(6) 2008, THE LEADS AND EXTENSIONS WERE EXPLANTED AND REPLACED. FOLLOW UP ON THE PATIENT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE PRODUCTS WERE NOT RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 97913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention