BEUDAMED
    FDA Adverse Event Summary report: N

    LAMITRODE 88C LEAD

    MDR report key: 1870897 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-01781
    Date Received
    September 29, 2010
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MANUFACTURER'S REPORT: 1627487-2010-01780. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PT WAS EXPERIENCING PHYSICAL DISCOMFORT. THE IPG AND LEAD WERE EXPLANTED ON (B)(6) 2008. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED. THE EXPLANTED IPG AND LEAD WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88C LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3289 69064

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention