BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE FREEHAND SYSTEM

    MDR report key: 298204 · Received September 27, 2000

    Report

    Report Number
    1530440-2000-00007
    Event Type
    Injury
    Date Received
    September 27, 2000
    Date of Event
    September 7, 2000
    Manufacturer
    NEUROCONTROL CORP.
    Product Code
    GZC
    Removal / Correction Number
    9028925-11/07/00-003
    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 THE FREEHAND SYSTEM HAND GRASP NEUROPROSTHESIS IN 1996 IN ANOTHER COUNTRY AS A PATIENT IN A CLINICAL TRIAL. ON JULY 11, 2000, THE PT EXPERIENCED INTERMITTENT MALFUNCTION OF THE DEVICE THAT PROGRESSED TO IMPLANT FAILURE TO DELIVER STIMULATION BY SEPTEMBER 2000. PT HAS NOT COME TO A DECISION ON WHETHER OR NOT TO HAVE THE IMPLANT REPLACED. THE PRODUCT MALFUNCTION DOES NOT POSE ANY RISK TO THE PT. B2: PRODUCT MALFUNCTION.

    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