BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3872092 · Received June 13, 2014

    Report

    Report Number
    3007566237-2014-01636
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 22, 2014
    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

    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 PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    BAIZABAL-CARVALLO, J.F., KAGNOFF, M.N., JIMENEZ-SHAHED, J., FEKETE, R., JANKOVIC, J. THE SAFETY AND EFFICACY OF THALAMIC DEEP BRAIN STIMULATION IN ESSENTIAL TREMOR: 10 YEARS AND BEYOND. JOURNAL OF NEUROLOGY, NEUROSURGERY, AND PSYCHIATRY. 2014;85(5):567-572. DOI: 10.1136/JNNP-2013-304943 SUMMARY: DEEP BRAIN STIMULATION (DBS) HAS PROVEN TO BE A SAFE AND EFFECTIVE THERAPY FOR REFRACTORY ESSENTIAL TREMOR, BUT INFORMATION REGARDING LONG-TERM OUTCOMES IS LACKING. WE AIMED TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF DBS IN PATIENTS WITH ESSENTIAL TREMOR. PATIENTS TREATED WITH DBS FOR ESSENTIAL TREMOR FOR AT LEAST 8 YEARS WERE EVALUATED IN THE ¿ON¿ AND ¿OFF¿ STATE USING THE FAHN¿TOLOSA¿MARIN TREMOR RATING SCALE, AND THEIR MEDICAL RECORDS WERE REVIEWED TO ASSESS COMPLICATIONS RELATED TO THIS THERAPY. WE STUDIED 13 PATIENTS (7 MEN): MEDIAN AGE AT EVALUATION 79 YEARS (RANGE 47¿88), MEDIAN AGE AT ELECTRODE IMPLANTATION 68 YEARS (RANGE 37¿78) AND MEAN TIME SINCE ELECTRODE IMPLANTATION 132.54 ±15.3 MONTHS (RANGE 114¿164). THE DIFFERENCE BETWEEN THE ¿OFF¿ AND ¿ON¿ STATE ON THE MOTOR ITEMS OF THE TREMOR RATING SCALE WAS 41.9% (58.62 VS 34.08, P<(><<)>0.001) IN THE NON-BLINDED AND 37.2% (56.07 VS 35.23, P<(> <<)>0.001) IN THE BLINDED RATING. DBS PROVIDED A FUNCTIONAL IMPROVEMENT OF 31.7% IN THE ¿ON¿ STATE (15.07 VS 22.07, P<(><<)>0.001). A TOTAL NON-BLINDED IMPROVEMENT IN THE TREMOR RATING SCALE OF 39% WAS OBSERVED IN THE ¿ON¿ STATE (49.15 VS 80.69, P<(><<)>0.001). DYSARTHRIA AND DISEQUILIBRIUM WERE COMMON IN PATIENTS WITH BILATERAL STIMULATION. A DBS-RELATED SURGERY (ELECTRODE REVISION OR INTERNAL PULSE GENERATOR EXCHANGE) WAS NECESSARY ON AVERAGE EVERY 47.9 MONTHS TO CONTINUE WITH THE DBS THERAPY. THALAMIC DBS IS A SAFE AND EFFECTIVE THERAPY IN PATIENTS WITH ESSENTIAL TREMOR FOLLOWED FOR UP TO 13 YEARS. REPORTED EVENT: ONE (B)(6) MALE PATIENT EXPERIENCED ELECTRODE MIGRATION OF AN UNKNOWN CAUSE WHICH REQUIRED AN ELECTRODE REVISION. IT WAS NOTED THAT THIS RESULTED IN A MARKED TREMOR IMPROVEMENT. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC 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
    349570 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention