BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 8 ELECTRODE LEAD

    MDR report key: 1823398 · Received August 25, 2010

    Report

    Report Number
    1627487-2010-01932
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 17, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE 1 OF 2. (SEE MFR # 162487-2010-02491 FOR DEVICE 2). THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. 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. 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

    DEVICE 1 OF 2. (SEE MFR # 162487-2010-02491 FOR DEVICE 2.) ON (B)(6)2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. IT WAS REPORTED THAT THE LEADS MIGRATED, CAUSING THE STIMULATION TO BE IN THE WRONG AREA. THE SYSTEM WAS EXPLANTED ON (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 8 ELECTRODE LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 3097234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other