BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD KIT, 30CM LENGTH

    MDR report key: 1790874 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01333
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    November 5, 2008
    Report Date
    November 26, 2008
    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

    EVAL - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS : THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. FAILED CONTINUITY TEST. LEAD WAS KINKED WITH ALL BROKEN WIRES. 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 INFO 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

    THE PT RECEIVED HIS SCS SYSTEM INCLUDING PERCUTANEOUS LEADS ON (B)(6)2007. IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS STIMULATION. LEAD IMPEDANCES WERE MEASURED AND FOUND TO BE HIGH. A FRACTURE ON THE LEAD WAS VISIBLE. THE LEAD WAS REPLACED ON (B)(6)2008. FOLLOW UP ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED LEAD WAS RETURNED TO ANS FOR EVAL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 30CM LENGTH SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3183 64147

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention