BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 8 PERCUTANEOUS LEAD

    MDR report key: 1852374 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02640
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE LEADS WERE VISUALLY INSPECTED AND NO ANOMALIES WERE FOUND. THE LEADS PASSED CONTINUITY TESTING AND ALL CHANNELS MEASURED LESS THAN 4 OHMS. STRESS TESTING DID NOT REVEAL ANY FAILURES. CONCLUSION - THE REPORTED COMPLAINT COULD NOT BE CONFIRMED FOR LEAD MIGRATION. BOTH LEADS, HOWEVER, PASSED LAB TESTING AND ARE FUNCTIONAL. 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

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT WHILE GETTING OUT OF HIS CAR, THE PT HEARD A POP COME FROM HIS BACK. PT CLAIMS THAT AFTER THAT, THE STIMULATION CHANGED. THE SALES REPRESENTATIVE MET WITH THE PT FOR REPROGRAMMING, BUT WAS UNABLE RECAPTURE ALL OF THE ORIGINAL COVERAGE AREAS. THE PT REPORTED FELLING SHARP PAINS DURING THE SESSION IN THIS THIGH AND BACK. AN X-RAY REVEALED THAT ONE OF THE LEADS HAD MIGRATED. ON (B)(6) 2010, THE LEADS WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 8 PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 3153429

    Patients

    Seq Age Sex Outcome Treatment
    1 Other