BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEHAND IMPLANTABLE RECEIVER STIMULATOR

    MDR report key: 306000 · Received November 22, 2000

    Report

    Report Number
    1530440-2000-00013
    Event Type
    Malfunction
    Date Received
    November 22, 2000
    Date of Event
    October 20, 2000
    Report Date
    October 20, 2000
    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 THE FREEHAND SYSTEM HAND GRASP NEUROPROSTHESIS IN 1997, IN SALISBURY UK. IN 2000, PT EXPERIENCED INTERMITTENT PAIN DURING HAND GRASP AND AT THE IMPLANT SITE. ATTEMPTS WERE MADE TO REPORGRAM THE PT'S SYSTEM TO RESOLVE ISSUE. LATER IN 2000, THE DEVICE WAS NOT DELIVERING STIMULATION AND SYMPTOMS ARE CONSISTENT WITH A MALFUNCTIONING IMPLANTABLE RECEIVER STIMULATOR. PT WOULD LIKE TO HAVE IMPLANT REPLACED. SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. B2: PRODUCT MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other