BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 6057360 · Received October 26, 2016

    Report

    Report Number
    3007566237-2016-03730
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    August 30, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WEERNINK, M.G., VAN TIL, J.A., VAN VUGT, J.P., MOVIG, K.L., GROOTHUIS-OUDSHOORN, C.G.M., IJZERMAN, M.J. INVOLVING PATIENTS IN WEIGH TING BENEFITS AND HARMS OF TREATMENT IN PARKINSON'S DISEASE. PLOS ONE. 2016;11(8)(1-16):E0160771. DOI:10.1371/JOURNAL.PONE.0160771 SUMMARY: LITTLE IS KNOWN ABOUT HOW PATIENTS WEIGH BENEFITS AND HARMS OF AVAILABLE TREATMENTS FOR PARKINSON¿S DISEASE (ORAL MEDICATION, DEEP BRAIN STIMULATION, INFUSION THERAPY). IN THIS STUDY WE HAVE (1) ELICITED PATIENT PREFERENCES FOR BENEFITS, SIDE EFFECTS AND PROCESS CHARACTERISTICS OF TREATMENTS AND (2) MEASURED PATIENTS¿ PREFERRED AND PERCEIVED INVOLVEMENT IN DECISION MAKING ABOUT TREATMENT. REPORTED EVENTS FOR GROUP 1 (N=18 (3 DBS PATIENTS), 13 M 5 F, AVG AGE=66±7 YRS): THREE PATIENTS REPORTED EXPERIENCING CONFUSION, HALLUCINATIONS AND PARANOIA. ACCORDING TO MOST PATIENTS THIS HAD A MAJOR INFLUENCE ON THEIR HEALTH RELATED QUALITY OF LIFE (HRQOL). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708605 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other