BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10354279 · Received August 2, 2020

    Report

    Report Number
    2182207-2020-00629
    Event Type
    Injury
    Date Received
    August 2, 2020
    Date of Event
    May 22, 2019
    Report Date
    August 2, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN. YANG, C., QIU, Y., WANG, J., WU, Y., HU, X., & AMP; WU, X. (2019). INTRACRANIAL HEMORRHAGE RISK FACTORS OF DEEP BRAIN STIMULATION FOR PARKINSON¿S DISEASE: A 2-YEAR FOLLOW-UP STUDY. JOURNAL OF INTERNATIONAL MEDICAL RESEARCH, 48(5), 030006051985674. DOI:10.1177/0300060519856747. 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. DATE OF EVENT: 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. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    YANG, C., QIU, Y., WANG, J., WU, Y., HU, X., & AMP; WU, X. (2019). INTRACRANIAL HEMORRHAGE RISK FACTORS OF DEEP BRAIN STIMULATION FOR PARKINSON¿S DISEASE: A 2-YEAR FOLLOW-UP STUDY. JOURNAL OF INTERNATIONAL MEDICAL RESEARCH, 48(5), 030006051985674. DOI:10.1177/0300060519856747. SUMMARY: THE LONG-TERM EFFICACY OF DEEP BRAIN STIMULATION (DBS) FOR TREATMENT OF PARKINSON¿S DISEASE (PD) IS WIDELY RECOGNIZED. 1¿8 A APPROXIMATELY 9000 PATIENTS WITH PD HAVE UNDERGONE DBS. THERE HAVE BEEN MANY SURGICAL TECHNIQUE REPORTS ON HOW TO REDUCE THE RISK OF INTRACRANIAL HEMORRHAGE (ICH) IN PATIENTS WITH PD WHO RECEIVED DBS. 9,10 THEREFORE, MANY METHODS HAVE BEEN USED TO REDUCE THE INCIDENCE AND VOLUME OF ICH. PROBLEMS THAT NEED TO BE ADDRESSED ARE REDUCING THE RISK OF ICH AND NEUROLOGICAL OUTCOMES THAT PATIENTS WILL HAVE AFTER ICH. THEREFORE, THIS STUDY AIMED TO DETERMINE RISK FACTORS AND THE LONG-TERM PROGNOSIS OF ICH IN PATIENTS WITH IDIOPATHIC PD WHO UNDERWENT DBS. REPORTED EVENTS: 11 PATIENTS EXPERIENCED INTRACRANIAL HEMORRHAGE AFTER IMPLANT. 1 PATIENT EXPERIENCED POSTOPERATIVE DELIRIUM AND MANIC SYMPTOMS. 1 PATIENT EXPERIENCED SEIZURES AFTER DISCHARGE AND ORAL ANTIEPILEPTIC DRUGS WERE ADMINISTERED TO CONTROL THE SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818606 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other