BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1904135 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02271
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    February 20, 2010
    Report Date
    February 22, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 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. (B)(4). 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

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2005. IT WAS REPORTED THAT DURING AN IPG REVISION ON (B)(6) 2010 FOR NORMAL BATTERY DEPLETION, THE DOCTOR ELECTED TO REPLACE TWO LEADS AS WELL. AFTER PLACEMENT OF BOTH LEADS TESTING SHOWED ALL CONTACTS AS INVALID. THE CASE WAS ABORTED AND THE TWO LEADS WERE REMOVED AT THAT TIME. BOTH LEADS ARE FROM THE SAME LOT AND WERE RETURNED TO ANS FOR EVALUATION. THE PATIENT HAS SUBSEQUENTLY RECEIVED HER NEW SCS SYSTEM ON (B)(6) 2010. 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 2879578

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention