BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXXESS PERCUTANEOUS LEAD

    MDR report key: 1790788 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01606
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    April 30, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 3 OF 4. 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 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 3 OF 4. REFERENCE MANUFACTURER¿S REPORTS: 1627487-2010-01604; 1627487-2010-01605 AND 1627487-2010-01583. THE PATIENT RECEIVED HER SCS SYSTEM CONSISTING OF 2 PERCUTANEOUS LEADS PLACED SUPRA-ORBITALLY (OFF-LABEL LOCATION), A DUAL EXTENSION AND AN IPG ON (B)(6) 2005. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION. AN X-RAY SHOWED THAT THE LEADS HAD NOT MOVED. LEAD IMPEDANCE TESTING SHOWED THAT 2 CONTACTS ON BOTH LEADS WERE INVALID. THE SCS SYSTEM WAS EXPLANTED BUT NOT RETURNED TO ANS FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXESS PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 4146 28050

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention