BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3813115 · Received May 15, 2014

    Report

    Report Number
    3007566237-2014-01330
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    October 13, 2013
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    MEHANNA, R., ITIN, I.. WHICH APPROACH IS BETTER: BILATERAL VERSUS UNILATERAL THALAMIC DEEP BRAIN STIMULATION IN PATIENTS WITH FRAGILE X-ASSOCIATED TREMOR ATAXIA SYNDROME. CEREBELLUM (LONDON, ENGLAND). 2014;13(2):222-225. DOI 10.1007/S12311-013-0530-7 SUMMARY: FRAGILE X¿ASSOCIATED TREMOR ATAXIA SYNDROME (FXTAS) IS A RELATIVELY RECENTLY DESCRIBED CONDITION THAT IS FREQUENTLY MISDIAGNOSED AS ESSENTIAL TREMOR AND THEN OCCASIONALLY TREATED AS SUCH WITH DEEP BRAIN STIMULATION (DBS) TO THE NUCLEUS VENTRALIS INTERMEDIUS OF THE THALAMUS (VIM). REPORTS OF ATAXIA WORSENING AFTER BILATERAL VIM DBS IN FXTAS PATIENTS ARE CONFLICTING, AND ONLY FIVE FXTAS PATIENTS TREATED WITH VIM DBS FOR INTRACTABLE TREMOR HAVE BEEN REPORTED IN THE LITERATURE, THREE OF WHOM HAVING UNDERGONE A BILATERAL PROCEDURE. WE REPORT A PATIENT WHO UNDERWENT A STAGED VIM DBS PROCEDURE, WITH EXCELLENT CONTRALATERAL HAND TREMOR CONTROL AND NO WORSENING OF ATAXIA AFTER THE FIRST PROCEDURE, BUT IMMEDIATE WORSENING OF HIS ATAXIA AFTER THE SECOND ONE, ARGUING IN FAVOR OF A UNILATERAL SURGICAL APPROACH FOR INTRACTABLE TREMOR IN FXTAS. REPORTED EVENTS: ONE MALE PATIENT WITH FRAGILE X-ASSOCIATED TREMOR ATAXIA SYNDROME (FXTAS) EXPERIENCED AN IMMEDIATE WORSENING OF HIS ATAXIA FOLLOWING THE IMPLANT OF A SECOND LEAD IN THE VENTRALIS INTERMEDIUS OF THE THALAMUS (VIM). THE REPORTER STATED THAT THE PATIENT INITIALLY UNDERWENT LEFT VIM DEEP BRAIN STIMULATION (DBS) IMPLANT WITH NEAR COMPLETE RESOLUTION OF THE RIGHT HAND TREMOR, BUT DUE TO THE PERSISTENCE OF THE PATIENT¿S LEFT HAND TREMOR, HE UNDERWENT A RIGHT VIM DBS SIX MONTHS LATER. THE REPORTER STATED THAT THE SECOND LEAD ALLOWED FOR GOOD CONTROL OF THE PATIENT¿S LEFT HAND TREMOR, BUT CAUSED AN IMMEDIATE PROGRESSION OF HIS ATAXIA AS WELL AS THE DEVELOPMENT OF COGNITIVE DECLINE, DYSARTHRIA, AND APRAXIA. IT WAS NOTED THAT A STROKE WAS RULED OUT AFTER EXTENSIVE WORK UP. THE REPORTER STATED THAT FOLLOWING THE IMPLANT, THE PATIENT USED A WALKER TO AMBULATE MOST OF THE TIME, COULD DRESS WITH DIFFICULTY, WOULD BE ABLE TO FIX A SANDWICH IF HIS WIFE LAID ALL THE INGREDIENTS OUT, AND HIS SPEECH WAS DIFFICULT TO UNDERSTAND. IT WAS NOTED THAT THE PATIENT¿S EXAMINATION WITH BOTH STIMULATORS ON WAS REMARKABLE ONLY FOR A MINI-MENTAL STATUS EXAM SCORE OF 28/30, SEVERE DYSARTHRIA, MINIMAL DYSMETRIA IN THE ARMS, MORE SIGNIFICANT DYSMETRIA IN THE LEGS, DYSDIADOCHOKINESIA, A WIDE BASED UNSTEADY GAIT, AND INABILITY TO AMB ULATE WITHOUT ASSISTANCE. IT WAS NOTED THAT THE PATIENT¿S SCALE FOR THE ASSESSMENT AND RATING OF ATAXIA SCORE WAS 19. THE REPORTER STATED THAT IT WAS CONCLUDED THAT THE PATIENT¿S SYMPTOMS WERE SECONDARY TO FXTAS AND WORSENED AFTER THE SECOND DBS SURGERY. IT WAS NOTED THAT THE PATIENT EXPERIENCED PROGRESSION OF SYMPTOMS IMMEDIATELY AFTER SURGERY AND BEFORE TURNING THE DBS ON, SUGGESTING THAT DBS IMPLANT, RATHER THAN ACTIVATION, MIGHT BE THE CAUSE OF ATAXIA AND DYSARTHRIA WORSENING. THE REPORTER STATED THAT THE WORSENING OF FXTAS SYMPTOMS WAS CLEARLY RELATED TO BILATERAL SURGERY DESPITE GOOD TREMOR CONTROL. THE SOURCE LITERATURE DID NOT INCLUDE ANY DEVICE INFORMATION. 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
    290439 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Disability