BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 17213422 · Received June 27, 2023

    Report

    Report Number
    3006630150-2023-03680
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    April 5, 2022
    Report Date
    June 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7046592. PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB1200S0, MODEL: DB-1200-S, SERIAL: (B)(6), BATCH: 736990. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7073806. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 5082425.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AT THE LEAD EXTENSION CONNECTION SITE. THE PATIENT EXPERIENCED REDNESS AND AN OPEN INCISION SITE. THE PHYSICIAN INDICATED THAT THE PATIENTS BODY REJECTED THE IMPLANTS FOR AN UNKNOWN REASON. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422927 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7046086 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention