BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE 8 EXTENSION

    MDR report key: 1842380 · Received August 31, 2010

    Report

    Report Number
    1627487-2010-02404
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE LEAD WAS VISUALLY INSPECTED AND BROKEN WIRES WERE OBSERVED AT THE EXTENSION STRAIN RELIEF. THE EXTENSION LEAD SEGMENT SHOWED SIGNS OF TWISTING. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BROKEN WIRES. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT WAS CONFIRMED. AS RECEIVED, THE EXTENSION'S WIRES WERE BROKEN. NO FUNCTIONAL TESTING WAS PERFORMED. ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. APPROXIMATELY 2 WEEKS LATER, THE PT LOST STIMULATION. AN IMPEDANCE CHECK REVEALED HIGH IMPEDANCE ON SEVERAL CONTACTS. ON (B)(6) 2010, THE PT UNDERWENT A REVISION PROCEDURE AND THE IMPEDANCE LEVELS OF THE LEAD AND EXTENSIONS WERE CHECKED. THE EXTENSION EXHIBITED HIGH IMPEDANCE AND WAS EXPLANTED AND REPLACED. UPON REMOVAL, A FRACTURE WAS OBSERVED NEAR THE TERMINAL END OF THE EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE 8 EXTENSION SPINAL CORD STIMULATION LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3383 3062363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other