BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE FREEHAND SYSTEM

    MDR report key: 288993 · Received August 4, 2000

    Report

    Report Number
    1530440-2000-00005
    Event Type
    Malfunction
    Date Received
    August 4, 2000
    Date of Event
    June 14, 1999
    Report Date
    July 2, 1999
    Manufacturer
    NEUROCONTROL CORP
    Product Code
    GZC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH FREEHAND SYSTEM HAND GRASP NEUROPROSTHESIS IN 1997. IN 1999, PT'S SYSTEM WAS NOT FUNCTIONING CORRECTLY AND PROGRESSED TO IMPLANT FAILURE TO DELIVER STIMULATION. PT HAD THE FREEHAND IMPLANTABLE RECEIVE STIMULATOR REPLACED IN 1999. DEVICE RELACEMENT HAS RESTORED FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE FREEHAND SYSTEM IMPLANTABLE HAND GRASP NEUROPROSTHESIS GZC NEUROCONTROL CORP 1060-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other