BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5237559 · Received November 19, 2015

    Report

    Report Number
    3007566237-2015-03390
    Event Type
    Injury
    Date Received
    November 19, 2015
    Report Date
    October 22, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    WESTBAY, L.C., CAO, L., BURNETT-ZEIGLER, I., REIZINE, N., BARTON, B., IPPOLITO, D., WEAVER, F.M., STROUPE, K.T. MENTAL HEALTH-RELATED HEALTHCARE USE FOLLOWING BILATERAL DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE. JOURNAL OF PARKINSON'S DISEASE. 2015;5(3):497-504. DOI 10.3233/JPD-140512. SUMMARY: THE SUBTHALAMIC NUCLEUS (STN) AND THE GLOBUS PALLIDUS INTERNUS (GPI) ARE BOTH EFFECTIVE TARGETS FOR DEEP BRAIN STIMULATION (DBS) TO RELIEVE MOTOR SYMPTOMS OF PARKINSON'S DISEASE. HOWEVER, STUDIES HAVE REPORTED VARIED EFFECTS ON MENTAL HEALTH-RELATED ADVERSE EVENTS AND DEPRESSED MOOD FOLLOWING DBS. DESPITE A BRIEF INCREASE IN MEDICATION USE FOLLOWING SURGERY, THIS STUDY SUGGESTS THAT MENTAL HEALTH HEALTHCARE USE AND COSTS ARE STABLE OVER TIME AND SIMILAR BETWEEN DBS TARGETS. PRIOR RESEARCH FINDINGS OF MENTAL HEALTH-RELATED ADVERSE EVENTS AND MOOD FOLLOWING DBS DID NOT TRANSLATE TO GREATER MENTAL HEALTH SERVICE UTILIZATION IN OUR COHORT. THE CHANGES SEEN IN THE YEAR FOLLOWING SURGERY MAY REFLECT TEMPORARY ADJUSTMENTS WITH STABILIZATION OVER TIME. REPORTED EVENTS: 1. 9 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) REQUIRED INPATIENT STAYS FOR MENTAL HEALTH NEEDS. 2. 3 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) RECEIVED NEW MENTAL HEALTH PRESCRIPTIONS WITHIN THE FIRST 12 MONTHS FOLLOWING DBS IMPLANT. THESE PATIENTS CONTINUED TO RECEIVE THE MENTAL HEALTH PRESCRIPTIONS THROUGH THE 36-MONTH FOLLOW-UP PERIOD. IT WAS NOTED THAT ANTIDEPRESSANTS WERE THE MOST FREQUENTLY PRESCRIBED PSYCHIATRIC MEDICATIONS; OTHER COMMONLY PRESCRIBED MENTAL HEALTH DRUG CLASSES INCLUDED ANTICONVULSANTS, BENZODIAZEPINE DERIVATIVES, AND ANTIPSYCHOTICS. 3. 18 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) RECEIVED NEW MENTAL HEALTH PRESCRIPTIONS WITHIN THE FIRST 12 MONTHS FOLLOWING DBS IMPLANT. IT WAS NOTED THAT ANTIDEPRESSANTS WERE THE MOST FREQUENTLY PRESCRIBED PSYCHIATRIC MEDICATIONS; OTHER COMMONLY PRESCRIBED MENTAL HEALTH DRUG CLASSES INCLUDED ANTICONVULSANTS, BENZODIAZEPINE DERIVATIVES, AND ANTIPSYCHOTICS. THESE PATIENTS DID NOT CONTINUE TO RECEIVE MENTAL HEALTH PRESCRIPTIONS THROUGH THE 36-MONTH FOLLOW-UP PERIOD. THIS DISCONTINUATION OF PRESCRIPTIONS SUGGESTED THAT THESE MIGHT BE TRANSITORY CHANGES RELATED TO DBS INTERVENTION AND NOT CHRONIC POST-OPERATIVE MENTAL HEALTH CONDITIONS. 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
    767998 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R