BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 1790807 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01512
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    September 29, 2009
    Report Date
    September 29, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. ONE LEAD HAS SEVERE KINK WITH ALL WIRES BROKEN 21 CM FROM STIM END IN BOTH LEAD SEGMENTS. OTHER LEAD PASSES ALL FUNCTIONAL TESTS. LAMITRODE PADDLES ARE CLEAR AND UNDAMAGED. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. 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

    THE PATIENT WAS IMPLANTED WITH HIS SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION AND THERE WAS CONFIRMED LEAD FRACTURE. THE PATIENT'S LEADS WERE EXPLANTED ON (B)(6) 2009 AND RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3219 2745756

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention