BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREL II

    MDR report key: 1692688 · Received May 14, 2010

    Report

    Report Number
    3007566237-2010-03963
    Event Type
    Death
    Date Received
    May 14, 2010
    Date of Event
    January 1, 2008
    Report Date
    April 14, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    LITERATURE: DILORENZO DJ, JANKOVIC J, SIMPSON RK, TAKEI H, POWELL SZ, LONG-TERM DEEP BRAIN STIMULATION FOR ESSENTIAL TREMOR: 12-YEAR CLINICOPATHOLOGIC F/U. MOV DISORD. 2010;25(2):232-238. SUMMARY: THIS ARTICLE DESCRIBES THE CLINICAL COURSE AND POSTMORTEM PATHOLOGICAL FINDING IN A PT WITH ET TREATED WITH DBS FOR 12 YEARS. THIS (B) (6) WOMAN HAD A 13 YEAR HISTORY OF PROGRESSIVE ET PRIOR TO IMPLANTATION OF BILATERAL DBS ELECTRODES IN THE REGION OF HER VIM THALAMIC NUCLEI IN 1996, PRODUCING IMMEDIATE RELIEF OF ARM TREMOR. HISTOPATHOLOGICAL EXAMINATION OF THE BRAIN, PERFORMED 12 YEARS AFTER THE INITIAL IMPLANTATION, DEMONSTRATED ELECTRODE CATHETER TRACTS RIMMED BY 20-25 MICRON SHEATH, WITH MULTINUCLEATED GIANT CELLS AND REACTIVE GLIOSIS. LYMPHOCYTIC INFILTRATION WAS SEEN BY L26 IMMUNOREACTIVITY WITH CD3 (T CELLS) STAINING PREDOMINATING OVER CD20 (B CELLS). CEREBELLAR AXONAL SPHEROIDS AND PURKINJE CELL LOSS WERE FOUND. THE MINIMAL FOREIGN BODY REACTION AND GLIOSIS AROUND THE ELECTRODES 12 YEARS AFTER IMPLANTATION SUPPORTS THE LONG-TERM SAFETY OF DBS. EVENT: THE PT'S MOST RECENT STIMULATION PARAMETER ADJUSTMENT WAS ON (B) (6) 2008. THE RIGHT SIDE IMPEDANCE VALUES WERE NORMAL. LEFT SIDE IMPEDANCE VALUES WERE >2000, >2000, 1,400, AND 1,834 OHMS WITH RESPECT TO THE CASE, RESPECTIVELY, FOR ELECTRODES 0 TO 3. FROM THESE LAST MEASUREMENTS, LEFT ELECTRODES 0 AND 1 MAY HAVE BEEN FRACTURED. ALTHOUGH, THE PT'S TREMOR AMPLITUDE WAS AT LEAST 75% LOWER WITH THE DBS TURNED ON COMPARED TO THAT WITH THE DBS OFF, SHE DEVELOPED POSTURAL INSTABILITY WHICH CONFINED HER TO A WHEELCHAIR. IN (B) (6) 2008, SHE WAS ADMITTED FOR PHYSICAL THERAPY FOR MUSCLE DISUSE ATROPHY, BUT WAS DISCHARGED AFTER 6 WEEKS WITH MINIMAL IMPROVEMENT. SHE DIED IN HER SLEEP ON (B) (6) 2008.

    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 75 YR Death| H EXPLANTED:| IMPLANTED:| LEAD: MODEL 3382, LOT# UNK| LOT# UNK| IMPLANTABLE NEURO STIMULATOR: MODEL 7424| IMPLANTED:| LEAD: MODEL 3382, LOT# UNK| IMPLANTED:| EXPLANTED:| EXPLANTED: