BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4727246 · Received April 24, 2015

    Report

    Report Number
    3007566237-2015-01107
    Event Type
    Injury
    Date Received
    April 24, 2015
    Report Date
    March 26, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS 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; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    DELI, G., ASCHERMANN, Z., ACS, P., BOSNYAK, E., JANSZKY, J., FALUDI, B., MAKKOS, A., KOVACS, M., KOMOLY, S., BALAS, I., DOCZI, T., KOVACS, N. BILATERAL SUBTHALAMIC STIMULATION CAN IMPROVE SLEEP QUALITY IN PARKINSON¿S DISEASE. JOURNAL OF PARKINSON¿S DISEASE. 2015. DOI: 10.3233/JPD-150540. SUMMARY: SLEEP PROBLEMS ARE AMONG THE MOST COMMON NON-MOTOR SYMPTOMS OF PARKINSON¿S DISEASE (PD). THE PD SLEEP SCALE 2ND VERSION (PDSS-2) IMPROVED THE ORIGINAL PDSS BY ADDING MORE ITEMS ON DIFFERENT ASPECTS OF SLEEP PROBLEMS, MAKING IT A MORE ROBUST TOOL TO EVALUATE THE SEVERITY OF SLEEP DISTURBANCES. HOWEVER, PREVIOUS STUDIES ON DEEP BRAIN STIMULATION (DBS) HAVE NOT USED THE PDSS-2. TO DETERMINE IF THE PDSS-2 COULD DETECT IMPROVEMENT RELIABLY IN SLEEP PROBLEMS AFTER BILATERAL SUBTHALAMIC NUCLEUS DBS FOR PD. IN THIS PROSPECTIVE STUDY, 25 CONSECUTIVE PATIENTS UNDERGOING DBS IMPLANTATION WERE ENROLLED. PATIENTS WERE EXAMINED TWICE: 1 WEEK PRIOR TO THE DBS IMPLANTATION (BASELINE) AND 12 MONTHS POSTOPERATIVELY. SEVERITY OF PD SYMPTOMS WERE ASSESSED BY THE MOVEMENT DISORDERS SOCIETY UNIFIED PD RATING SCALE (MDS-UPDRS) AND THE NON-MOTOR SYMPTOMS SCALE (NMSS). PRESENCE AND SEVERITY OF SLEEP DISTURBANCES WERE SPECIFICALLY MEASURED BY PDSS-2. TOTAL SCORE OF MDS-UPDRS IMPROVED FROM 81 (MEDIAN, INTERQUARTILE-RANGE: 63¿103) TO 55 POINTS (MEDIAN, IQR: 4 6¿75, P <(><<)> 0.001). HEALTH-RELATED QUALITY OF LIFE, MEASURED BY PDQ-39, ALSO IMPROVED FROM 29 (IQR: 18¿40) TO 15 (IQR: 9¿28) POINTS (P = 0.002). MOST DOMAINS OF NMSS ALSO IMPROVED. AT BASELINE 13 PATIENTS REPORTED SLEEP PROBLEMS, BUT 1 YEAR AFTER DBS IMPLANTATION ONLY 3 DID (P = 0.012). ALTHOUGH ONLY 6 OUT OF 15 ITEMS SHOWED A SIGNIFICANT DECREASE AFTER DBS IMPLANTATION, THE TOTAL SCORE OF PDSS-2 DECREASED FROM 24 (IQR: 17¿32) TO 10 (IQR: 7¿18) POINTS (P <(><<)> 0.001). BASED ON OUR RESULTS, PDSS-2 CAN DETECT IMPROVEMENTS IN SLEEP QUALITY RELIABLY AFTER DBS IMPLANTATION. REPORTED EVENT: 25 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE DID NOT EXPERIENCE AN AVERAGE IMPROVEMENT IN HALLUCINATORY SYMPTOMS AND SEXUAL DYSFUNCTION FOLLOWING DBS TREATMENT. IT WAS NOTED THAT THERE WAS AN INCREASE IN MEAN SCORE FROM 0.3 TO 0.4 FOR NON-MOTOR SYMPTOMS SCALE (NMSS)-PART 4 (HALLUCINATIONS) AND FROM 4.3 TO 4.8 FOR NMSS-PART 8 (SEXUAL PROBLEMS). 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
    272870 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Other