BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1790856 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01635
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    September 17, 2009
    Report Date
    September 17, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 COMPLAINT 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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT SHE WAS NOT RECEIVING STIMULATION THE FOLLOWING DAY. X-RAYS SHOWED THAT ALL CONNECTIONS WERE INTACT. ONE LEAD WAS REPLACED ON AN UNK DATE. THE EXPLANTED LEAD WAS RETURNED TO ANS FOR EVALUATION. NO FURTHER INFO 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 2798856

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention