BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEHAND SYSTEM

    MDR report key: 380189 · Received February 28, 2002

    Report

    Report Number
    1530440-2002-00001
    Event Type
    Injury
    Date Received
    February 28, 2002
    Date of Event
    December 1, 2001
    Report Date
    February 28, 2002
    Manufacturer
    NEUROCONTROL CORP.
    Product Code
    GZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS IMPLANTED WITH THE FREEHAND SYSTEM HAND GRASP NEUROPROSTHESIS IN 2001. IN 2001 DRAINAGE WAS OBSERVED ON THE PT'S CLOTHING THROUGH AN OPENING IN THE SKIN ON THE UPPER-MIDDLE ARM. THE PT WAS TREATED BY A PHYSICIAN AND RELEASED. TEN DAYS LATER THE PT WAS SEEN BY A SURGEON WHO EVALUATED THE PT AND TREATED WITH ANTIBIOTICS. APPROX ONE WEEK LATER, THE PT WAS SEEN AGAIN BY THE SURGEON, WHO HAS CULTURES TAKEN, DETERMINED THE PT TO BE MRSA-POSITIVE, AND FURTHER TREATED WITH ANTIBIOTICS. APPROX ONE ADDITIONAL WEEK LATER, THE SURGEON EXPLANTED THE IMPLANTABLE RECEIVER-STIMULATOR (IRS) AND ELECTRODE CONNECTORS. DURING THE EXPLANT SURGERY AN ELECTRODE LEAD WAS FOUND TO BE KINKED NEAR THE CONNECTOR SITE, WHICH APPEARED TO BE THE SOURCE OF THE SKIN EROSION. THE SURGEON DID NOT EXPLANT THE ELECTRODES AT THAT TIME AS THE INFECTION APPEARED NOT TO HAVE SPREAD TO THE ELECTRODES AND THE SURGEON WANTED TO AVOID THE INVASIVE PROCEDURE REQUIRED FOR ELECTRODE EXPLANTATION IF POSSIBLE. ANTIBIOTIC THERAPY WAS CONTINUED. HOWEVER, IN 2002 THE PT WAS SEEN AGAIN BY THE SURGEON, WHO DETERMINED THAT THE ANTIBIOTIC THERAPY WAS INEFFECTIVE AND EXPLANTED THE ELECTRODES. THE ANTIBIOTIC THERAPY WAS CONTINUED FOLLOWING ELECTRODE EXPLANTATION AND THE INFECTION HAS SINCE RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention