BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 1008126 · Received March 6, 2008

    Report

    Report Number
    2182207-2008-01100
    Event Type
    Injury
    Date Received
    March 6, 2008
    Report Date
    February 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODES: 2011, 2045 -NOT LABELED. DEVICE CODES: 1475, 2584 -LABELED. JOURNAL REFERENCE: ANHEIM M, FRAIX V, CHABARDES S, KRACK P, BENABID A-L, POLLAK P. LIFETIME OF ITREL II PULSE GENERATORS FOR SUBTHALAMIC NUCLEUS STIMULATION IN PARKINSONS DISEASE. MOV DISORD 2007; 22 (16): 2436-2439.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ANHEIM M, FRAIX V, CHABARDES S, KRACK P, BENABID A-L, POLLAK P. LIFETIME OF ITREL II PULSE GENERATORS FOR SUBTHALAMIC NUCLEUS STIMULATION IN PARKINSONS DISEASE. MOV DISORD 2007; 22 (16): 2436-2439. THE ARTICLE DESCRIBES THE RESULTS OF A LONG TERM STUDY WHERE 49 PTS WERE TREATED FOR SYMPTOMS OF ADVANCED PARKINSONS DISEASE WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN). THE PURPOSE OF THE STUDY WAS TO EVALUATE THE LIFETIME OF CHRONIC STIMULATORS (ITREL II). A NUMBER OF ADVERSE EVENTS RELATED TO STIMULATOR END-OF-LIFE (NORMAL BATTERY DEPLETION) WERE INCLUDED IN THE ARTICLE. UNILATERAL IPG END-OF-LIFE TO SUDDEN AND SEVERE AGGRAVATION OF PARKINSONIAN SYMPTOMS IN 10 PTS. UNILATERAL IPG END-OF-LIFE LED ASPIRATION PNEUMONIA OR RESPIRATORY FAILURE IN 4 PTS. TREATMENT AND OUTCOME INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II MHY MEDTRONIC NEUROMODULATION 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R 7424 (N=1)| LEAD UNK (N=2)| LEAD EXT (N=2)