BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 88 SURGICAL LEAD

    MDR report key: 1870718 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02276
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    April 3, 2009
    Report Date
    June 18, 2009
    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

    EVAL METHOD: 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. LEAD WAS RETURNED INCOMPLETE AND COULD NOT BE FUNCTIONALLY TESTED. 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 1 OF 2. REFERENCE MFR REPORT 1627487-2010-02275. THE PT RECEIVED HIS SCS SYSTEM CONSISTING OF AN IPG AND ONE PADDLE LEAD ON (B)(6) 2008. IT WAS REPORTED THAT THE PT CLAIMED THE SYSTEM NEVER FUNCTIONED PROPERLY. THE SYSTEM WAS EXPLANTED ON (B)(6) 2009 AND RETURNED TO THE MFR FOR EVAL. F/U ON THE PT FOUND NO ADDITIONAL ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3288 119470

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention