BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 2484883 · Received March 9, 2012

    Report

    Report Number
    3007566237-2012-00503
    Event Type
    Injury
    Date Received
    March 9, 2012
    Date of Event
    January 1, 2012
    Report Date
    February 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONTINUED CONCOMITANT MEDICAL PRODUCTS: NEUROSTIMULATOR MODEL UNKNOWN SERIAL# UNKNOWN IMPLANTED: UNKNOWN EXPLANTED: UNKNOWN; LEAD MODEL UNKNOWN LOT# UNKNOWN IMPLANTED: UNKNOWN EXPLANTED: UNKNOWN; LEAD MODEL UNKNOWN LOT# UNKNOWN IMPLANTED: UNKNOWN EXPLANTED: UNKNOWN. (B)(6).

    Description of Event or Problem · 1

    LITERATURE: ULLMAN, MICHAEL, VINATA VEDAM-MAI, ANDREW S. RESNICK, ANTHONY T. YACHNIS, NIKOLAUS R. MCFARLAND, STACY MERRITT, PAMELA Z EILMAN, KELLY D. FOOTE, AND MICHAEL S. OKUN. "DEEP BRAIN STIMULATION RESPONSE IN PATHOLOGICALLY CONFIRMED CASES OF MULTIPLE SYSTEM ATROPHY." PARKINSONISM AND RELATED DISORDERS 18 (2012): 86-88. PRINT. SUMMARY: DEEP BRAIN STIMULATION IS A TREATMENT FOR SELECT CASES OF MEDICATION REFRACTORY MOVEMENT DISORDERS INCLUDING PARKINSON'S DISEASE. DEEP BRAIN STIMULATION HAS NOT BEEN RECOMMENDED FOR TREATMENT IN MULTIPLE SYSTEM ATROPHY PATIENTS. HOWEVER, THE PAUCITY OF LITERATURE DOCUMENTING THE EFFECTS OF DEEP BRAIN STIMULATION IN MULTIPLE SYSTEM ATROPHY PATIENTS AND THE REVELATION OF A LEVODOPA RESPONSIVE SUBTYPE OF MULTIPLE SYSTEM ATROPHY SUGGESTS FURTHER INVESTIGATION IS NECESSARY. THIS STUDY SUMMARIZES THE POSITIVE AND NEGATIVE EFFECTS OF DEEP BRAIN STIMULATION TREATMENT IN TWO PATHOLOGICALLY CONFIRMED MULTIPLE SYSTEM ATROPHY PATIENTS FROM THE (B)(6) DEEP BRAIN STIMULATION-BRAIN TISSUE NETWORK. CLINICAL DIAGNOSIS FOR THE TWO PATIENT CASES DID NOT MATCH THE NEUROPATHOLOGICAL DIAGNOSIS. WE NOTED THAT IN BOTH PATHOLOGICALLY CONFIRMED MULTIPLE SYSTEM ATROPHY PATIENTS, DEATH OCCURRED AS A RESULT OF MYOCARDIAL INFARCTION. IMPORTANTLY, THERE WAS REPORTED TRANSIENT BENEFIT IN LEVODOPA RESPONSIVE FEATURES THAT INDICATE DEEP BRAIN STIMULATION MAY BE AN OPTION FOR SELECT MULTIPLE SYSTEM ATROPHY PATIENTS. REPORTED EVENTS: THE PATIENT UNDERWENT A DBS IMPLANTATION ON THE LEFT SIDE IN THE GLOBUS PALLIDUS INTERNUS (GPI) IN (B)(6) 2004. THE MEASURED LEAD TIP LOCATION FOR THE LEFT LEAD WAS -24.6, -0.5, -3.6 (X,Y,Z), AND WAS FELT TO BE LATERAL TO THE OPTIMAL POSITION. FOLLOWING SURGERY THE PATIENT DEVELOPED EXPRESSIVE APHASIA WHICH RESOLVED OVER SEVERAL WEEKS WITH THERAPY. THE PATIENT LATER DEVELOPED A WORSENING GAIT. A BRAIN MRI REVEALED A LACUNAR INFARCT IN THE PALLIDUM/INTERNAL CAPSULE REGION. THE LEFT GPI_DBS AND STROKE REPORTEDLY IMPROVED HIS RIGHT HEMIBODY PARKINSONIAN SYMPTOMS. ALTHOUGH THE DBS LEAD WAS SUB-OPTIMALLY PLACED, THE INFARCT MAY HAVE OFFERED A BENEFICIAL LESION EFFECT. THE PATIENT UNDERWENT RIGHT GPI-DBS IMPLANTATION AND REPOSITIONING OF HIS LEFT DBS LEAD IN (B)(6) 2005. THE MEASURED LEAD TIP LOCATION FOR THE RIGHT LEAD WAS 22.19, 4.79, -2.5 (X,Y,Z), AND THE MEASURED LEAD TIP LOCATION FOR THE REVISED LEFT LEAD WAS -20.69, 7.2, 11.5 (X,Y,Z). THE LEFT LEAD WAS DORSALLY PLACED ANTERIOR AND SHALLOW TO THE OPTIMAL LOCATION, BUT THE PATIENT REPORTED SATISFACTORY IMPROVEMENT IN HIS SYMPTOMS. COMPLICATIONS AFTER THE SECOND DBS PROCEDURE INCLUDED WORSENING OF HIS SPEECH INTELLIGIBILITY AND PRONOUNCED SIALORRHEA. IT WAS UNCLEAR FROM THE DBS-BTN NOTES WHETHER THIS WAS DIRECT RESULT OF SURGERY, OR DUE TO NATURAL DISEASE PROGRESSION. THE PATIENT EXPIRED AT THE (B)(6) FROM A MYOCARDIAL INFARCTION. HE SHOWED NO EARLY CARDIAC PROBLEMS, BUT PATHOLOGIC EVALUATION REVEALED ARTERIAL/ARTERIOLAR SCLEROSIS. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Life Threatening| R