BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44C LEAD, 60CM LENGTH

    MDR report key: 1904296 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02091
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    May 2, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. EVALUATION: RESULTS: LEAD FAILS CONTINUITY TEST AND HAS BROKEN WIRES. 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 MFR REPORT # 1627487-2010-02092. THE PATIENT RECEIVED HER SCS SYSTEM CONSISTING OF TWO LEADS AND AN IPG ON AN UNKNOWN DATE. THE LEADS WERE IMPLANTED IN THE OCCIPITAL AREA (OFF-LABEL PLACEMENT). IT WAS REPORTED THAT THE PATIENT STATED THE SYSTEM NEVER WORKED FOR HER AND SHE REQUESTED THE SYSTEM BE EXPLANTED. THE SYSTEM WAS EXPLANTED ON (B)(6) 2008. THE EXPLANTED DEVICES WERE RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44C LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention