BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE 8 EXTENSION, 30CM LENGTH

    MDR report key: 1790675 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01706
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    September 22, 2009
    Report Date
    September 22, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 2. 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. FAILED CONTINUITY TEST. BROKEN WIRES IN HEADER. 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

    DEVICE 2 OF 2. REF MFR REPORT # 1627487-2010-01705. THE PT RECEIVED HER SCS SYSTEM CONSISTING OF AN IPG, TWO LEADS AND TWO EXTENSIONS ON (B)(6) 2007. IT WAS REPORTED THAT THE PT COULD ONLY GET MOTOR STIMULATION. ONE LEAD AND EXTENSION WAS REPLACED ON (B)(6) 2009. THE EXPLANTED PRODUCTS WERE RETURNED TO ANS FOR EVALUATION. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE 8 EXTENSION, 30CM LENGTH SPINAL CORD STIMULATION EXTENSION LGW ADVANCED NEUROMODULATION SYSTEMS 3383 65205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention