BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4869587 · Received June 25, 2015

    Report

    Report Number
    3007566237-2015-01762
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    April 30, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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. (B)(4).

    Description of Event or Problem · 1

    MARTINEZ-FERNANDEZ, R., PELISSIER, P., QUESADA, J.L., KLINGER, H., LHOMMÉE, E., SCHMITT, E., FRAIX, V., CHABARDES, S., MERTENS, P., CASTRIOTO, A., KISTNER, A., BROUSSOLLE, E., POLLAK, P., THOBOIS, S., KRACK, P. POSTOPERATIVE APATHY CAN NEUTRALISE BENEFITS IN QUALITY OF LIFE AFTER SUBTHALAMIC STIMULATION FOR PARKINSON'S DISEASE. JOURNAL OF NEUROLOGY, NEUROSURGERY, AND PSYCHIATRY. 2015 APR 30. DOI:10.1136/JNNP-2014-310189. SUMMARY: SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) IMPROVES MOTOR SYMPTOMS OF PARKINSON¿S DISEASE, LEADING TO IMPROVEMENT IN HEALTHRELATED QUALITY OF LIFE (HRQOL). HOWEVER, AN EXCESSIVE DECREASE IN DOPAMINERGIC MEDICATION CAN LEAD TO A WITHDRAWAL SYNDROME WITH APATHY AS THE PREDOMINANT FEATURE. THE PRESENT STUDY AIMS TO ASSESS THE IMPACT OF POSTOPERATIVE APATHY ON HRQOL. A COHORT OF 88 PATIENTS WHO UNDERWENT STNDBS WAS DIVIDED INTO TWO GROUPS, THOSE WHO WERE APATHETIC AT 1 YEAR AND THOSE WHO WERE NOT, AS MEASURED BY THE STARKSTEIN SCALE. HRQOL WAS ASSESSED USING THE PARKINSON¿S DISEASE QUESTIONNAIRE 39 ((B)(4)) AND WAS COMPARED BETWEEN THE TWO GROUPS. WE ALSO COMPARED ACTIVITIES OF DAILY LIVING, MOTOR IMPROVEMENT AND MOTOR COMPLICATIONS (UNIFIED PARKINSON¿S DISEASE RATING SCALE, UPDRS), DEPRESSION AND ANXIETY, AS WELL AS COGNITION AND DRUG DOSAGES. BASELINE CHARACTERISTICS AND POSTOPERATIVE COMPLICATIONS WERE RECORDED. ONE YEAR AFTER SURGERY, 27.1% OF PATIENTS SUFFERED FROM APATHY. WHILE MOTOR IMPROVEMENT WAS SIGNIFICANT AND E QUIVALENT IN BOTH THE APATHY (-40.4% OF UPDRS MOTOR SCORE) AND NON-APATHY GROUPS (-48.6%), THE PDQ-39 SCORE DID NOT IMPROVE IN THE APATHY GROUP (-5.5%; P=0.464), WHEREAS IT IMPROVED SIGNIFICANTLY (-36.7%; P=0.001) IN THE NON-APATHY GROUP. CHANGE IN APATHY SCORES C ORRELATED SIGNIFICANTLY WITH CHANGE IN HRQOL SCORES (R=0.278, P=0.009). DEPRESSION AND ANXIETY SCORES REMAINED UNCHANGED FROM BASELINE IN THE APATHY GROUP (P=0.409, P=0.075), WHILE THEY IMPROVED SIGNIFICANTLY IN PATIENTS WITHOUT APATHY (P=0.006, P=0.001). A SIGNIF ICANT CORRELATION WAS FOUND BETWEEN CHANGES IN APATHY AND DEPRESSION (R=0.594, P=0.001). THE DEVELOPMENT OF APATHY AFTER STN-DBS CAN CANCEL OUT THE BENEFITS OF MOTOR IMPROVEMENT IN TERMS OF HRQOL. SYSTEMATIC EVALUATION AND MANAGEMENT OF APATHY OCCURRING AFTER SUBT HALAMIC STIMULATION APPEARS MANDATORY. REPORTED EVENTS: 1. 1 PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE EXPERIENCED AN INFECTION, WHICH LED TO THE REMOVAL OF THE SUBCUTANEOUS MATERIAL AND ELECTRODES. 2. 1 PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE SUFFERED A SYMPTOMATIC CEREBRAL HEMORRHAGE. 3. 1 PATIENT WITH DBS FOR PARKINSON¿S DISEASE REQUIRED REOPERATION DUE TO ELECTRODE MISPLACEMENT. 4. 1 PATIENT WITH DBS FOR PARKINSON¿S DISEASE REQUIRED REOPERATION DUE TO ELECTRODE MIGRATION. 5. 1 PATIENT WITH DBS FOR PARKINSON¿S DISEASE REQUIRED REOPERATION DUE TO CABLE FRACTURE. 6. 3 PATIENTS WITH DBS FOR PARKINSON¿S DISEASE EXPERIENCED PSYCHOSIS. THIS WAS NOTED TO BE A TRANSIENT POSTOPERATIVE BEHAVIORAL/COGNITIVE DISTURBANCE SIDE EFFECT NOT ASSOCIATED WITH BRAIN LESIONS. 7. 2 PATIENTS WITH DBS FOR PARKINSON¿S DISEASE EXPERIENCED HALLUCINATIONS. THIS WAS NOTED TO BE A TRANSIENT POSTOPERATIVE BEHAVIORAL/COGNITIVE DISTURBANCE SIDE EFFECT NOT ASSOCIATED WITH BRAIN LESIONS. 8. 1 PATIENT WITH DBS FOR PARKINSON¿S DISEASE EXPERIENCED URINARY RETENTION AS A TRANSIENT SIDE EFFECT. 9. 1 PATIENT WITH DBS FOR PARKINSON¿S DISEASE EXPERIENCED TRANSIENT SYMPTOMATIC CONTUSIONS ALONG THE ELECTRODE TRAJECTORY CAUSING PSYCHOSIS. 10. 1 PATIENT WITH DBS FOR PARKINSON¿S DISEASE EXPERIENCED PNEUMONIA WITH TRANSIENT CARDIORESPIRATORY ARREST IN THE CONTEXT OF A POS TOPERATIVE AKINETIC CRISIS. 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
    413091 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Life Threatening| O| R