BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANS QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 890744 · Received August 6, 2007

    Report

    Report Number
    1627487-2007-00015
    Event Type
    Other
    Date Received
    August 6, 2007
    Date of Event
    May 22, 2007
    Report Date
    August 6, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 3 OF 3. REFERENCE MANUFACTURER REPORT NUMBER 1627487-2007-00013. LEAD WAS RETURNED TO MANUFACTURER INCOMPLETE, WITH THE TERMINAL END CUT OFF. FUNCTIONAL TESTING COULD NOT BE PERFORMED ON THE LEAD. DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. THERE WERE NO PROBLEMS FOUND VISUALLY WITH THIS LEAD. LEAD COULD NOT BE TESTED FUNCTIONALLY SINCE WAS RETURNED INCOMPLETE. ANS INC. CORPORATION HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS, INC CORPORATION DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    SEE MFR REPORT # 1627487-2007-00013. THE PT WAS IMPLANTED WITH AN IPG AND 2 LEADS IN 2007. INTRAOPERATIVE TESTING ON THE SYSTEM WAS NOT PERFORMED DUE TO THE PT REPORTING DISCOMFORT DURING THE PROCEDURE. ALL DIAGNOSTIC SYSTEM CHECKS CONFIRMED THAT THE LEADS WERE CONNECTED PROPERLY TO THE IPG, AND THERE WERE NO MALFUNCTIONS OF SYSTEM FOUND. IT WAS REPORTED THAT SINCE RECEIVING THE IMPLANTED SYSTEM, THE PT EXPERIENCED WEAKNESS IN BOTH LEGS PLUS A LACK OF BOWEL CONTROL. THE PHYSICIAN EXPLANTED THE SYSTEM THE FOLLOWING MONTH. FOLLOW-UP ON THE PT A FEW WEEKS POST-EXPLANT FOUND THAT SHE HAS SHOWN SOME IMPROVEMENT AND IS ABLE TO MOVE HER LEGS MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANS QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC 3146 65768

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other