BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1870770 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-01762
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 21, 2007
    Report Date
    August 30, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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. (B)(4). 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

    DEVICE 2 OF 3. REFERENCE MANUFACTURER REPORTS: 1627487-2010-01761 & 1627487-2010-01763. THE PT RECEIVED HIS SCS SYSTEM CONSISTING OF TWO PERCUTANEOUS LEADS AND AN IPG ON (B)(6) 2006. IN (B)(6) 2007, THE PT PRESENTED TO THE FACILITY FOR A LEAD REVISION. THE PHYSICIAN DID NOT SPECIFY WHICH OF THE PT'S TWO LEADS WAS BEING REVISED OR THE REASON FOR THE REVISION; THEREFORE A REPORT IS BEING SUBMITTED FOR BOTH LEAD LOTS. IT WAS REPORTED THAT WHEN THE PHYSICIAN DISCONNECTED THE LEAD FROM THE IPG, HE FOUND ONE OF THE LEAD'S ELECTRODES HAD COME OFF AND WAS LODGED IN THE HEADER OF THE DEVICE. THE PHYSICIAN WAS UNABLE TO REMOVE THE ELECTRODE FROM THE IPG HEADER; THE IPG WAS EXPLANTED AND REPLACED. THE EXPLANTED IPG WAS RETURNED FOR ANALYSIS. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 64905

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention