BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4939909 · Received July 24, 2015

    Report

    Report Number
    3007566237-2015-02085
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    March 16, 2015
    Report Date
    July 1, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    QURESHI, A. A., CHENG, J. J., SUNSHINE, A. N., WU, A., PONTONE, G. M., CASCELLA, N., LENZ, F. A., GRILL, S. E., ANDERSON, W. S. POSTOPERATIVE SYMPTOMS OF PSYCHOSIS AFTER DEEP BRAIN STIMULATION IN PATIENTS WITH PARKINSON'S DISEASE. NEUROSURGICAL FOCUS. 2015; 38(6):E5. DOI: 10.3171/2015.3.FOCUS1523 SUMMARY: CASES OF POSTOPERATIVE PSYCHOSIS IN PARKINSON¿S DISEASE PATIENTS RECEIVING DEEP BRAIN STIMULATION (DBS) TREATMENT HAVE PREVIOUSLY BEEN PUBLISHED. HOWEVER, THE MAGNITUDE OF SYMPTOM INCIDENCE AND THE CLINICAL RISK FACTORS ARE CURRENTLY UNKNOWN. THIS RETROSPECTIVE STUDY SHEDS LIGHT ON THESE ISSUES BY INVESTIGATING PSYCHOSIS IN A GROUP OF 128 PARKINSON¿S DISEASE PATIENTS WHO RECEIVED DBS IMPLANTS. A RETROSPECTIVE CHART REVIEW WAS PERFORMED TO OBTAIN SURGERY DATES, FOLLOW-UP CLINIC VISIT DATES, AND ASSOCIATED STIMULATION PARAMETER SETTINGS (CONTACTS IN USE AND THE POLARITY OF EACH ALONG WITH STIMULATION VOLTAGE, FREQUENCY, AND PULSE WIDTH) FOR EACH PATIENT. UNIFIED PARKINSON¿S DISEASE RATING SCALE II THOUGHT DISORDER SCORES, USED AS A CLINICAL ASSESSMENT TOOL TO EVALUATE THE PRESENCE OF PSYCHOSIS AT EACH VISIT, WERE ALSO COLLECTED. THE DATA WERE COMPILED INTO A DATABASE AND ANALYZED. THE LIFETIME INCIDENCE OF PSYCHOSIS IN THIS COHORT OF PATIENTS WAS 28.1%. THE DATA SUGGEST THAT RISK OF PSYCHOSIS REMAINS FAIRLY CONSTANT THROUGHOUT THE FIRST 5 YEARS AFTER IMPLANTATION OF A DBS SYSTEM AND THAT PATIENTS OLDER AT THE TIME OF RECEIVING THE FIRST DBS IMPLANT ARE NOT ONLY MORE LIKELY TO DEVELOP PSYCHOSIS, BUT ALSO TO DEVELOP SYMPTOMS SOONER THAN THEIR YOUNGER COUNTERPARTS. FURTHER ANALYSIS PROVIDES EVIDENCE THAT PSYCHOSIS IS LARGELY INDEPENDENT OF THE CLINICALLY USED ELECTRODE CONTACT AND OF STIMULATION PARAMETERS PRIOR TO PSYCHOSIS ONSET. ALTHOUGH SYMPTOMS OF PSYCHOSIS ARE WIDELY SEEN IN PATIENTS WITH PARKINSON¿S DISEASE IN THE YEARS FOLLOWING STIMULATOR PLACEMENT, RESULTS OF THE PRESENT SUGGEST THAT MOST PSYCHOSES OCCURRING POSTOPERATIVELY ARE LIKELY INDEPENDENT OF IMPLANTATION AND STIMULATION SETTINGS. REPORTED EVENT: 9 FEMALES WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE DEVELOPED PSYCHOSIS WITHIN FIVE YEARS OF IMPLANT. IT WAS NOTED THAT IN MANY CASES, PSYCHOTIC SYMPTOMS WERE TRANSIENT AND, IN FEWER CASES, THE SYMPTOMS WERE MORE LONG-LIVED. 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
    482865 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Other