BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEHAND SYSTEM

    MDR report key: 442470 · Received February 13, 2003

    Report

    Report Number
    1530440-2003-00001
    Event Type
    Injury
    Date Received
    February 13, 2003
    Report Date
    January 15, 2003
    Manufacturer
    NEUROCONTROL CORP.
    Product Code
    GZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH FREEHAND IRS IN 2001 AS PART OF A LOWER EXTREMITY STUDY NOT SPONSORED BY THE MANUFACTURER. THE FREEHAND IMPLANTABLE INTRAMUSCULAR (IM) ELECTRODE TO CHANNEL 1 ORIGINALLY GAVE POOR RESPONSE FOR APPROX. 1 1/2 YEARS, THEN GAVE NO RESPONSE AT ALL. NEW IM ELECTRODE WAS IMPLANTED DURING A REVISION SURGERY IN 2003 AND DID ELICIT A GOOD MUSCLE RESPONSE FROM ALL SOURCES EXCEPT CHANNEL 1 OF THE IRS DURING TESTING. REPLACEMENT IM ELECTRODE WAS LEFT CONNECTED TO CHANNEL 1 EVEN THOUGH THERE WAS NO APPARENT OUTPUT; THE IRS HAS PROGRAMMABLE CURRENT ON THE OTHER 7 CHANNELS AND APPEARS TO OPERATE CORRECTLY. IT IS SUSPECTED THAT THE IM CONNECTOR MAY HAVE MALFUNCTIONED. FOLLOW UP REPORT WILL BE SUBMITTED ONCE FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEHAND SYSTEM HAND GRASP NEUROPROSTHESIS GZC NEUROCONTROL CORP. 1060-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN