BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3230050 · Received July 16, 2013

    Report

    Report Number
    3007566237-2013-02365
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    April 6, 2011
    Report Date
    August 23, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387, LOT# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    SCHRADER, C., CAPELLE, H.H., KINFE, T.M., BLAHAK, C., BAZNER, H., LUTJENS, G., DRESSLER, D., KRAUSS, J.K. GPI-DBS MAY INDUCE A HYPO KINETIC GAIT DISORDER WITH FREEZING OF GAIT IN PATIENTS WITH DYSTONIA. NEUROLOGY. 2011;77(5):483-488. SUMMARY: STIMULATION-INDUCED HYPOKINETIC GAIT DISORDERS WITH FREEZING OF GAIT (FOG) HAVE BEEN REPORTED ONLY RECENTLY AS ADVERSE EFFECTS OF DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) IN PATIENTS WITH DYSTONIA. THE AIM OF THIS WORK WAS TO DETERMINE THE FREQUENCY AND THE NATURE OF THIS GPI-DBS¿INDUCED PHENOMENON. WE RETROSPECTIVELY SCREENED OUR DATABASE OF PATIENTS WITH DYSTONIA WHO UNDERWENT DBS. PATIENTS WITH FOCAL, SEGMENTAL, OR GENERALIZED DYSTONIA OF PRIMARY OR TARDIVE ORIGIN AND NO GAIT DISORDER DUE TO LOWER LIMB DYSTONIA BEFORE DBS, BILATERAL PALLIDAL STIMULATION, AND A FOLLOW-UP FOR MORE THAN 6 MONTHS WERE INCLUDED. REPORTS OF ADVERSE EVENTS WERE ANALYZED, AND GAIT ABNORMALITIES WERE SCORED BY COMPARING PREOPERATIVE AND POSTOPERATIVE VIDEO RECORDINGS USING MOVEMENT DISORDER SOCIETY¿SPONSORED REVISION OF THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (MDS-UPDRS) ITEMS 3.10 (GAIT) AND 3.11 (FOG). TO ASSESS THE ROLE OF GPI-DBS IN GAIT ABNORMALITIES, DBS WAS PAUSED FOR 24 HOURS. GAIT AND FOG WERE ASSESSED 30 MINUTES, 2 HOURS, AND 24 HOURS AFTER RESTARTING DBS. FINALLY, A STANDARDIZED ADJUSTMENT ALGORITHM WAS PERFORMED TRYING TO ELIMINATE THE GAIT DISORDER. OF A COLLECTIVE OF 71 PATIENTS WITH DYSTONIA, 6 PRESENTED WITH A NEW GAIT DISORDER (8.5%; 2 MEN, 4 WOMEN, MEAN AGE (B)(6), 2 CRANIOCERVICAL, 1 DYT-1 SEGMENTAL, 1 TRUNCAL, 2 TARDIVE DYSTONIA). GPI-DBS IMPROVED BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE MOTOR SCORE BY 54% AND DISABILITY SCORE BY 52%. MDS-UPDRS ITEM 3.10 WORSENED FROM 0.5 ( 0.8) TO 2.0 ( 0.9) AND ITEM 3.11 FROM 0 TO 2.5 ( 0.5).THE GAIT DISORDER DISPLAYED SHUFFLING STEPS AND DIFFICULTIES WITH GAIT INITIATION AND TURNING. INCREASING VOLTAGES IMPROVED DYSTONIA BUT TRIGGERED FOG, SOMETIMES WORSENING OVER A PERIOD OF A FEW HOURS. IT VANISHED WITHIN MINUTES AFTER CEASING DBS. ELECTRODE MISPLACEMENT WAS RULED OUT. IN ALL BUT ONE PATIENT, NO OPTIMAL CONFIGURATION WAS FOUND DESPITE EXTENSIVE TESTING OF SETTINGS (MONOPOLAR, BIPOLAR, PULSE WIDTH 60¿210 S, FREQUENCY 60¿180 HZ). NEVERTHELESS, A COMPROMISE BETWEEN OPTIMAL STIMULATION FOR DYSTONIA AND ELICITING FOG WAS ACHIEVED IN EACH CASE. A HYPOKINETIC GAIT DISORDER WITH FOG CAN BE A COMPLICATION OF GPI-DBS. EVENT: (B)(6) FEMALE PATIENT WITH TARDIVE DYSTONIA EXPERIENCED GAIT DISORDER AFTER INITIATION OF PALLIDAL DEEP BRAIN STIMULATION (DBS). THE SYMPTOMS OF THE GAIT DISORDER WERE BRADYKINESIA, GAIT IGNITION FAILURE, POSTURAL INSTABILITY, AND FALLS. PATIENT HAD HIP FRACTURE BECAUSE OF FALLS AS A SEQUEL OF FREEZE OF GAIT. WHEN STOPPING DBS, GAIT IMPROVED IN PATIENT TO BASELINE LEVEL WITHIN 30 MINUTES. IT RE-EMERGED ALMOST IMMEDIATELY AFTER TURNING ON THE DEVICE. COMPROMISE BETWEEN OPTIMAL STIMULATION FOR DYSTONIA AND ELICITING FREEZE OF GAIT WAS ACHIEVED IN EACH CASE. 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
    328372 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Other