BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENESISXP DUAL 4- CHANNEL IPG

    MDR report key: 890742 · Received August 6, 2007

    Report

    Report Number
    1627487-2007-00013
    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 1 OF 3. ADVANCED NEUROMODULATION SYSTEM, INC HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCE OF THE PT'S HISTORY TO THE EVENT REPORTED.

    Description of Event or Problem · 1

    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 GENESISXP DUAL 4- CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC 3644 45805A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other