BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1834180 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-02031
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    December 10, 2007
    Report Date
    December 12, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: - REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT, HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. 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

    THE PT RECEIVED HIS SCS SYSTEM ON (B)(6)2007. IT WAS REPORTED THAT SEVERAL LEAD CONTACTS WERE GIVING INVALID READINGS AND THE STIMULATION PATTERN HAD CHANGED. IT WAS SUSPECTED THAT THE LEAD HAD MIGRATED. IT WAS REPORTED THAT THE PT HAD LIFTED A HEAVY OBJECT AND EXPERIENCED THE ISSUE AFTERWARD. 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 NOT 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, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 84808

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention