BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1870532 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-01779
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    May 21, 2008
    Report Date
    June 6, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - 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 REFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MANUFACTURER'S REPORT # 1627487-2010-01778. THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED, THE PATIENT FELL, CAUSING ONE OF HIS LEADS TO MIGRATE. THE LOT NUMBER OF THE EXPLANTED LEAD WAS NOT PROVIDED IN THE REPORT; THEREFORE, A REPORT IS BEING SUBMITTED FOR BOTH OF THE PATIENT'S LEADS. FOLLOW UP ON THE PATIENT FOUND THAT HE WAS EXPERIENCING SOME OVERSTIMULATION BUT NO FURTHER REVISIONS WERE PERFORMED. THE EXPLANTED LEAD WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 87063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention