BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 16237853 · Received January 24, 2023

    Report

    Report Number
    3006630150-2023-00224
    Event Type
    Injury
    Date Received
    January 24, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7098961. PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(4), BATCH: 537963. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7089805. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: DB-2202-45.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION DBS PATIENT DEVELOPED AN INFECTION AT THE LEAD-EXTENSION CONNECTION BEHIND THE RIGHT EAR. THE PATIENT HAD SYMPTOMS OF PURULENT DISCHARGE, REDNESS, AND SWELLING. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE OF THE DBS SYSTEM. A CULTURE WAS TAKEN BUT THE RESULTS ARE UNAVAILABLE. THE PATIENT WAS NOTED TO BE FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203813 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7098956 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention