BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE 8 PERCUTANEOUS LEAD

    MDR report key: 1645794 · Received March 19, 2010

    Report

    Report Number
    1627487-2010-00119
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 21, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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 EVENT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFO 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

    IT WAS REPORTED THAT THE PT HAD NO STIMULATION AND ALL IMPEDANCES WERE INVALID.

    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 175683

    Patients

    Seq Age Sex Outcome Treatment
    1 Other