BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2704939 · Received August 17, 2012

    Report

    Report Number
    3007566237-2012-02012
    Event Type
    Injury
    Date Received
    August 17, 2012
    Date of Event
    March 20, 2012
    Report Date
    July 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. 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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT.

    Description of Event or Problem · 1

    LITERATURE: NAZZARO, J. M., PAHWA, R., LYONS, K. E. LONG-TERM BENEFITS IN QUALITY OF LIFE AFTER UNILATERAL THALAMIC DEEP BRAIN STIMULATION FOR ESSENTIAL TREMOR. JOURNAL OF NEUROSURGERY. 2012;117(1):156-161. DOI: 10.3171/2012.6.JNS112316A SUMMARY: THE GOAL OF THIS STUDY WAS TO EVALUATE SHORT- AND LONG-TERM BENEFITS IN QUALITY OF LIFE (QOL) AFTER UNILATERAL DEEP BRAIN STIMULATION (DBS) FOR ESSENTIAL TREMOR (ET). PATIENTS WHO RECEIVED UNILATERAL DBS OF THE VENTRAL INTERMEDIATE NUCLEUS OF THE THALAMUS BETWEEN 1997 AND 2010 AND WHO HAD AT LEAST 1 FOLLOW-UP EVALUATION AT LEAST 1 YEAR AFTER SURGERY WERE INCLUDED. THEIR QOL WAS ASSESSED WITH THE PARKINSON DISEASE QUESTIONNAIRE-39 (PDQ-39), AND ET WAS MEASURED WITH THE FAHN-TOLOSA-MARIN TREMOR RATING SCALE (TRS) PRIOR TO SURGERY AND THEN POSTOPERATIVELY WITH THE STIMULATION IN THE ON MODE. NINETY-ONE PATIENTS ((B)(6)) WERE INCLUDED IN THE ANALYSIS. THE TRS TOTAL, TARGETED TREMOR, AND ACTIVITIES OF DAILY LIVING (ADL) SCORES WERE SIGNIFICANTLY IMPROVED COMPARED WITH PRESURGICAL SCORES UP TO 12 YEARS. THE PDQ-39 ADL, EMOTIONAL WELL-BEING, STIGMA, AND TOTAL SCORES WERE SIGNIFICANTLY IMPROVED UP TO 7 YEARS AFTER SURGERY COMPARED WITH PRESURGICAL SCORES. AT THE LONGEST FOLLOW-UP, ONLY THE PDQ-39 STIGMA SCORE WAS SIGNIFICANTLY IMPROVED, AND THE PDQ-39 MOBILITY SCORE WAS SIGNIFICANTLY WORSENED. UNILATERAL THALAMIC STIMULATION SIGNIFICANTLY REDUCES ET AND IMPROVES ADL SCORES FOR UP TO 12 YEARS AFTER SURGERY, AS MEASURED BY THE TRS. THE PDQ-39 TOTAL SCORE AND THE DOMAINS OF ADL, EMOTIONAL WELL-BEING, AND STIGMA WERE SIGNIFICANTLY IMPROVED UP TO 7 YEARS. ALTHOUGH SCORES WERE IMPROVED COMPARED WITH PRESURGERY, OTHER THAN STIGMA, THESE BENEFITS DID NOT REMAIN SIGNIFICANT AT THE LONGEST (UP TO 12 YEARS) FOLLOW-UP, PROBABLY RELATED IN PART TO CHANGES DUE TO AGING AND COMORBIDITIES. REPORTED EVENTS: ONE PATIENT HAD A LEAD REVISION DUE TO INCORRECT PLACEMENT 3 WEEKS AFTER IMPLANT. ONE PATIENT HAD A LEAD REVISION DUE TO FRACTURE FOUR MONTHS AFTER IMPLANT. TWO PATIENTS HAD A LEAD REVISION DUE TO LOSS OF BENEFIT AT THE 2-7 YEAR FOLLOW UP. ONE PATIENT HAD A LEAD REVISION DUE TO LEAD FRACTURE AT THE 2-7 YEAR FOLLOW UP. ONE PATIENT HAD A LEAD REVISION DUE TO LEAD MIGRATION AT THE 2-7 YEAR FOLLOW UP. THREE PATIENTS HAD A LEAD REVISION DUE TO LOSS OF BENEFIT AT THE 7-12 YEAR FOLLOW UP. 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 NEU_INS_STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention