BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1657143 · Received April 5, 2010

    Report

    Report Number
    3007566237-2010-02753
    Event Type
    Malfunction
    Date Received
    April 5, 2010
    Date of Event
    February 28, 2010
    Report Date
    March 8, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    LITERATURE: BEWERNICK BH, HURLEMANN R, MATUSCH A, ET AL. NUCLEUS ACCUMBENS DEEP BRAIN STIMULATION DECREASES RATINGS OF DEPRESSION AND ANXIETY IN TREATMENT-RESISTANT DEPRESSION. BIOL PSYCHIATRY. 2010;67(2):110-116. SUMMARY: THE ARTICLE DESCRIBES THE LONG-TERM EFFECTS OF DBS IN THE NUCLEUS ACCUMBENS IN TEN PTS SUFFERING FROM VERY RESISTANT FORMS OF DEPRESSION. REPORTED EVENT: THE ARTICLE NOTED, ONE PT EXPERIENCED LEAD DISLODGEMENT. ALL THE PTS HAD UNDERGONE BILATERAL LEAD PLACEMENT. IT WAS UNK IF THE PT UNDERWENT INTERVENTION TO CORRECT THE ISSUE, HOWEVER, IT WAS NOTED ALL ADVERSE EFFECTS RELATED TO STIMULATION COULD BE COUNTERACTED BY PARAMETER ADJUSTMENTS. NO PT EXERCISED THE OPTION TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNK| LEAD: MODEL 3387, LOT# UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNK| EXPLANTED:| LEAD: MODEL 3387, LOT# UNK