BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44 SURGICAL LEAD

    MDR report key: 1904378 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02220
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 23, 2009
    Report Date
    September 24, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS ARE REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. NO TESTING PERFORMED ON INCOMPLETE LEAD. 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 3 OF 3. REFERENCE MANUFACTURER REPORTS: 1627487-2010-02218 & 1627487-2010-02219. THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT BOTH THE LEADS AND THE IPG WERE EXPLANTED AND REPLACED DUE TO UNACCEPTABLE IMPEDANCES ON (B)(6) 2010. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES WERE REPORTED. THE EXPLANTED PRODUCTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3263 2744024

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention