BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 30CM LENGTH

    MDR report key: 1834204 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-02065
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    October 23, 2007
    Report Date
    January 11, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. EVALUATION - 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. 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2010-02066. THE PT (B)(6) RECEIVED HER SCS SYSTEM INCLUDING PERCUTANEOUS LEADS ON (B)(6)2007. IT WAS REPORTED THAT STIMULATION WOULD TURN OFF FOR A FEW SECONDS, FOLLOWED BY AN OVERSTIMULATION SENSATION WHEN IT TURNS BACK ON. THE LEAD WAS REPLACED ON (B)(6)2007. IT WAS REPORTED THAT THIS DID NOT RESOLVE THE PROBLEM. THE PHYSICIAN ATTEMPTED TO ADD AN EXTENSION ON (B)(6)2007 BUT THE EXTENSION WOULD NOT PROPERLY CONNECT TO THE LEAD. BOTH THE EXPLANTED LEAD AN EXTENSION WERE RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION 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