BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 2543490 · Received April 20, 2012

    Report

    Report Number
    3007566237-2012-00832
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    March 2, 2011
    Report Date
    April 11, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL EVENT DATES WERE NOT PROVIDED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS.

    Description of Event or Problem · 1

    LITERATURE: FACTORS PREDICTING PROTRACTED IMPROVEMENT AFTER PALLIDAL DBS FOR PRIMARY DYSTONIA: THE ROLE OF AGE AND DISEASE DURATION IOANNIS U. ISAIAS, JENS VOLKMANN, ANDREAS KUPSCH, JEAN-MARC BURGUNDER, JILL L. OSTREM, RON L. ALTERMAN, HUBERTUS MAXIMILIAN MEHDORN, THOMAS SCHO¨NECKER, JOACHIM K. KRAUSS, PHILIP STARR, RENE REESE, ANDREA A. KU¨HN, W. M. MICHAEL SCHU¨PBACH, MICHELE TAGLIATI. J NEUROL (2011) 258:1469¿1476. DOI 10.1007/S00415-011-5961-9. ABSTRACT: ABSTRACT IN MANY PATIENTS, OPTIMAL RESULTS AFTER PALLIDAL DEEP BRAIN STIMULATION (DBS) FOR PRIMARY DYSTONIA MAY APPEAR OVER SEVERAL MONTHS, POSSIBLY BEYOND 1 YEAR AFTER IMPLANT. IN ORDER TO ELUCIDATE THE FACTORS PREDICTING SUCH PROTRACTED CLINICAL EFFECT, WE RETROSPECTIVELY REVIEWED THE CLINICAL RECORDS OF 44 PATIENTS WITH PRIMARY DYSTONIA AND BILATERAL PALLIDAL DBS IMPLANTS. PATIENTS WITH FIXED SKELETAL DEFORMITIES, AS WELL AS THOSE WITH A HISTORY OF PRIOR ABLATIVE PROCEDURES, WERE EXCLUDED. THE BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE (BFMDRS) SCORES AT BASELINE, 1 AND 3 YEARS AFTER DBS WERE USED TO EVALUATE CLINICAL OUTCOME. ALL SUBJECTS SHOWED A SIGNIFICANT IMPROVEMENT AFTER DBS IMPLANTS (MEAN BFMDRS IMPROVEMENT OF 74.9% AT 1 YEAR AND 82.6% AT 3 YEARS). DISEASE DURATION (DD, MEDIAN 15 YEARS, RANGE 2-42) AND AGE AT SURGERY (AS, (B)(6)) SHOWED A SIGNIFICANT NEGATIVE CORRELATION WITH DBS OUTCOME AT 1 AND 3 YEARS. A PARTITION ANALYSIS, USING DD AND AS, CLUSTERED SUBJECTS INTO THREE GROUPS: YOUNGER SUBJECTS WITH SHORTER DD (N = 19, AS\27, DD B 17); OLDER SUBJECTS WITH SHORTER DD (N = 8, DD B 17, AS C 27); OLDER SUBJECTS WITH LONGER DD (N = 17, DD[17, AS C 27). YOUNGER PATIENTS WITH SHORT DD BENEFITTED MORE AND FASTER THAN OLDER PATIENTS, WHO HOWEVER CONTINUED TO IMPROVE 10% ON AVERAGE 1 YEAR AFTER DBS IMPLANTS. OUR DATA SUGGEST THAT SUBJECTS WITH SHORT DD MAY EXPECT TO ACHIEVE A BETTER GENERAL OUTCOME THAN THOSE WITH LONGER DD AND THAT AS MAY INFLUENCE THE TIME NECESSARY TO ACHIEVE MAXIMAL CLINICAL RESPONSE. REPORTED EVENT: TWO PATIENT EXPERIENCED DEVICE INFECTIONS, EACH OF WHICH WAS TREATED BY REMOVING THE INFECTED DEVICE COMPONENTS AND RE-IMPLANTING FOLLOWING AN APPROPRIATE COURSE OF INTRAVENOUS ANTIBIOTICS. ONE PATIENT SUFFERED EXTENSION CABLE FRACTURES, WHICH REQUIRED SURGICAL REPLACEMENT. THE ARTICLE INCLUDED THE FOLLOWING DEVICE SPECIFICS: ALL SUBJECTS INCLUDED IN THIS STUDY UNDERWENT MICROELECTRODE GUIDED, FRAME-BASED STEREOTACTIC IMPLANTATION OF DBS LEADS [MODEL 3387 OR MODEL 3389 (2 PATIENTS), MEDTRONIC] 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 NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Required Intervention