BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 15427485 · Received September 15, 2022

    Report

    Report Number
    3006630150-2022-04765
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    August 11, 2022
    Report Date
    December 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729836544
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB220145DC0, MODEL: DB-2201-45-DC, SERIAL: (B)(4), BATCH: 680024. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7013741. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7029458.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN OPEN WOUND AND INFECTION OVER THE LEAD/LEAD EXTENSION SITES. THE PATIENT RECEIVED ANTIBIOTICS FOR THE INFECTION. IT IS NOT KNOWN IF THE INFECTION WAS CAUSED BY THE DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428072 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2201-45-DC 678566 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention