BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD

    MDR report key: 12154959 · Received July 12, 2021

    Report

    Report Number
    2182207-2021-01222
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    May 6, 2021
    Report Date
    July 12, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ONLY ONE PATIENT'S AGE WAS LISTED, AND IT WAS >(B)(6) YEARS OLD. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IMPACT OF DEEP BRAIN STIMULATION ON QUALITY OF LIFE AND MOTOR SYMPTOMS IN PARKINSON¿S DISEASE AND X-LINKED DYSTONIA PARKINSONISM: THE PHILIPPINE EXPERIENCE. ARJAY T. DANNUG, FRACHESCA GABRIELLE C. GABRIEL, MA. CLAUDIA YSABEL L. MACIAS, CID CZARINA E. DIESTA. DOI.O RG/10.1016/J.PARKRELDIS.2021.04.026 ABSTRACT: BACKGROUND AND OBJECTIVES: DEEP BRAIN STIMULATION (DBS) IS INDISPUTABLE IN IMPROVING MOTOR SYMPTOMS OF PARKINSON¿S DISEASE (PD) AND X-LINKED DYSTONIA PARKINSONISM (XDP)(4,9,22,23,26). HOWEVER, A DISCREPANCY BETWEEN THIS IMPROVEMENT AND THE PERCEIVED QUALITY OF LIFE (QOL) HAS BEEN OBSERVED. THIS STUDY AIMS TO INVESTIGATE CHANGES AND CORRELATION BETWEEN QUALITY OF LIFE, MOTOR SYMPTOMS AND MEDICATION DOSING. METHODOLOGY: THIS PROSPECTIVE OBSERVATIONAL STUDY ENROLLED 13 PATIENTS (6 PD, 7 XDP) WHO UNDERWENT DBS FROM 2017 TO 2018. QUALITY OF LIFE CHANGES WERE DETERMINED BY PARKINSON¿S DISEASE - 39 (PDQ-39 ENGLISH AND FILIPINO VERSIONS) AT BASELINE, 6 MONTHS AND 12 MONTH AFTER DBS. MOTOR SYMPTOMS AND MEDICATION DOSING WERE ALSO EVALUATED WITHIN THE SAME PERIOD AND CORRELATED WITH QOL CHANGES. RESULTS AND DISCUSSION: THERE IS A SIGNIFICANT REDUCTION OF PDQ-39 MEAN SCORES[F(1.06,11.64) = 18.235; P = 0.001; ¿P2 = 0.624] BETWEEN BASELINE AND 6 MONTHS AMONG XDP PATIENTS (P = 0.018) AND BASELINE AND 12 MONTHS AMONG PD PATIENTS (P = 0.027) AND XDP PATIENTS (P <(><<)> 0.001). SPECIFIC DOMAINS WITH SIGNIFICANT IMPROVEMENT WERE STIGMA, COGNITION, MOBILITY, ADLS, COMMUNICATION AND BODILY DISCOMFORT. CORRELATING THESE WITH CHANGES IN MOTOR SYMPTOMS, ONLY MOBILITY FOR PD AND ADLS FOR XDP WERE POSITIVELY RELATED. CONCLUSION: THIS STUDY HAS SHOWN THE POSITIVE IMPACT OF DBS IN IMPROVING QOL AMONG PD AND XDP PATIENTS OVER A 12-MONTH PERIOD. REPORTED EVENTS: IT WAS REPORTED THAT 1 PATIENT EXPERIENCED INTRACRANIAL HEMORRHAGE POST-OPERATIVELY. THEY WERE MANAGED CONSERVATIVELY MINIMIZING CONTACT WITH DBS LEADS, THUS MAINTAINING ITS VIABILITY. UPON STABILIZATION FROM ICH, DBS WAS EVENTUALLY TURNED ON. THE SUBJECTS PRE-EXISTING HYPERTENSION, TARGET AND TECHNIQUE WERE IDENTIFIED AS HAVING A SIGNIFICANT EFFECT ON THEIR RISK OF INTRACRANIAL HEMORRHAGE. IT WAS REPORTED THAT 1 PATIENT HAD SUBACUTE SURGICAL SITE INFECTION, WHICH WAS MANAGED ACCORDINGLY WITH ANTIBIOTICS AND THEY MAINTAINED THE INTEGRITY OF THE DBS LEADS. 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
    1051518 LEAD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other