BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7606887 · Received June 15, 2018

    Report

    Report Number
    3007566237-2018-01800
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    April 1, 2018
    Report Date
    June 15, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. KARL, JA., OUYANG, B., COLLETTA, K., VERHAGEN METMAN, L. LONG-TERM SATISFACTION AND PATIENT-CENTERED OUTCOMES OF DEEP BRAIN STIMULATION IN PARKINSON'S DISEASE. BRAIN SCI. 2018;8(4). DOI: 10.3390/BRAINSCI8040060 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) IS AN EFFECTIVE AND PROVEN TREATMENT OPTION FOR PATIENTS WITH ADVANCED PARKINSON¿S DISEASE (PD). LONG-TERM OUTCOMES (>5 YEARS) HAVE DEMONSTRATED SUSTAINED IMPROVEMENT IN OBJECTIVE MOTOR SYMPTOMS; HOWEVER, FEW STUDIES HAVE EVALUATED PATIENT-CENTERED OUTCOMES OTHER THAN QUALITY OF LIFE (QOL). A LOCALLY DEVELOPED DBS-PATIENT-CENTERED OUTCOMES QUESTIONNAIRE WAS ADMINISTERED TO PD PATIENTS >5 YEARS POST-DBS. ALL QUESTIONS WERE SCORED ON A TEN-POINT SCALE, WHEREBY 0 REPRESENTED THE MOST ¿POSITIVE¿ ANSWER AND 10 THE MOST ¿NEGATIVE¿ ANSWER. PRE-OPERATIVE SCALES WERE REPEATED AT THE TIME OF SURVEY. FIFTY-TWO PATIENTS (MEAN 8.2 = 2.6 YEARS POST-DBS) WERE INCLUDED. SATISFACTION WAS HIGH WITH MEDIAN SCORE (RANGE) OF 1/10 (0¿8) AT THE TIME OF SURVEY. PATIENTS ENDORSED HAVING MADE THE CORRECT DECISION BY UNDERGOING DBS, WITH A SCORE OF 0 (0¿10), WOULD CHOOSE TO HAVE DBS AGAIN, WITH A SCORE OF 0 (0¿10), AND WOULD RECOMMEND DBS TO OTHERS, WITH A SCORE OF 0 (0¿10). PRE-OPERATIVE EXPECTATION TARGET WAS SET AT A HIGH LEVEL WITH A SCORE OF 2 (0¿10). PARKINSON¿S DISEASE QOL (PDQ-39) QUESTIONNAIRE SUMMARY INDEX (SI) SCORES WERE, MEAN (SD), 2.1 (18.2) ABOVE BASELINE (P = 0.44). THOSE WITH WORSENING IN PDQ-39-SI SCORES HAD LESS SATISFACTION WITH DBS (RS = 0.57, P = 0.0001). THIS IS THE FIRST STUDY TO ASSESS LONG-TERM PATIENT SATISFACTION WITH STN DBS. WE ARE CURRENTLY COLLECTING DATA PROSPECTIVELY TO CONFIRM THE RESULTS OF THESE PRELIMINARY FINDINGS. REPORTED EVENTS: 1. A PATIENT WITH BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) HAD BEEN EXPLANTED BY AT LEAST 5 YEARS AFTER IMPLANT FOR UNSPECIFIED REASONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449859 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention