BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3538390 · Received December 26, 2013

    Report

    Report Number
    3007566237-2013-04176
    Event Type
    Injury
    Date Received
    December 26, 2013
    Date of Event
    June 13, 2013
    Report Date
    December 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    HASSAN, A., WU, S. S., SCHMIDT, P., DAI, Y., SIMUNI, T., GILADI, N., BLOEM, B. R., MALATY, I. A. OKUN, M. S. HIGH RATES AND THE RISK FACTORS FOR EMERGENCY ROOM VISITS AND HOSPITALIZATION IN PARKINSON'S DISEASE. PARKINSONISM <(>&<)> RELATED DISORDERS. 2013;19(11):949-954.DOI: 10.1016/J.PARKRELDIS.2013.06.006. SUMMARY: PARKINSON¿S DISEASE (PD) PATIENTS ARE HOSPITALIZED MORE FREQUENTLY THAN THEIR PEERS AS A RESULT OF FALLS, PSYCHOSIS, INFECTIONS AND OTHER MEDICAL COMPLICATIONS. HOWEVER, PATIENT-SPECIFIC RISK FACTORS FOR HOSPITALIZATION ARE UNCLEAR. TO IDENTIFY RATES AND RISK FACTORS FOR HOSPITAL ENCOUNTERS (EMERGENCY ROOM [ER] VISITS OR HOSPITALIZATION) AMONG PEOPLE WITH PD. 3415 PD PARTICIPANTS (MEAN AGE 67 _ 10 YEARS, DISEASE DURATION 9 _ 6 YEARS, H<(>&<)>Y 2 47%, H<(>&<)>Y 3 26%) ENROLLED IN THE PROSPECTIVE INTERNATIONAL MULTICENTER NPF-QII STUDY. ONE-YEAR FOLLOW-UP DATA WAS AVAILABLE FOR 1030 PATIENTS. RATES AND RISK FACTORS FOR HOSPITAL ENCOUNTERS WERE DETERMINED AT BASELINE AND AFTER ONE YEAR FOLLOW-UP. OF 3415 PD PARTICIPANTS AT STUDY ENTRY, 1120 (33%) REPORTED AT LEAST ONE HOSPITAL ENCOUNTER. ASSOCIATIONS WERE: LONGER TIMED UP-AND-GO TEST (OR: 1.33), INCREASED COMORBIDITIES (OR: 1.25), MOTOR FLUCTUATIONS (OR: 1.32), AND DEEP BRAIN STIMULATION (DBS) (OR: 2.49). OF THESE 1120 PERSONS, 311 HAD FOLLOW-UP DATA AND 158 (51%) HAD A REPEAT ENCOUNTER ONE YEAR LATER, ASSOCIATED WITH HIGHER H<(>&<)>Y STAGE, FLUCTUATIONS, AND LOWER HEALTH-RELATED QUALITY-OF-LIFE. OF 2295 PARTICIPANTS WITHOUT A HOSPITAL ENCOUNTER AT BASELINE, 719 HAD FOLLOW-UP DATA AND 178 (25%) HAD A FIRST HOSPITAL ENCOUNTER ONE YEAR LATER. RISK FACTORS WERE FEMALE GENDER, COMORBIDITIES, LOWER COGNITION, FLUCTUATIONS, AND DBS. ONE-THIRD OF PEOPLE WITH PD HAD A HOSPITAL ENCOUNTER EACH YEAR, AND ONE-HALF OF THOSE HAD A REPEAT ENCOUNTER. THESE HIGH RATES CORRELATED WITH DISEASE SEVERITY, COMORBIDITIES AND DBS. THERE IS AN URGENT NEED TO DEVELOP PROGRAMS TO REDUCE PD HOSPITAL ENCOUNTERS. REPORTED EVENT: 172 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE (PD) HAD A HOSPITAL ENCOUNTER. THE REPORTER STATED THAT THE HOSPITAL ENCOUNTERS INCLUDED ANY ADMISSION FOR EITHER A PD-RELATED OR NON-PD RELATED CAUSE AND INCLUDED ELECTIVE ADMISSIONS. THE TOP TWO REASONS FOR HOSPITAL ENCOUNTERS WERE REPORTEDLY INJURY OR INFECTION. IT WAS NOTED THAT SOME PATIENTS DID NOT REPORT A REASON FOR HOSPITALIZATION. 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
    675641 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization