BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 22527216 · Received July 16, 2025

    Report

    Report Number
    2124215-2025-47831
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    June 16, 2025
    Report Date
    July 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    00191506023577
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(6). BATCH: 781422. UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7133782. UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7134721. UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. BATCH: 35161557. UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C BATCH: 35107770 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED DRAINAGE AT THE LEAD EXTENSION SITE INCISION. A WOUND WASH WAS PERFORMED IN AN EFFORT TO SALVAGE THE IMPLANTED SYSTEM. HOWEVER, DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE INFECTION HAD SPREAD TO BOTH THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET AND BURR HOLE INCISION SITES. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED. ACCORDING TO THE PHYSICIAN, THE INFECTION WAS NOT BELIEVED TO BE DEVICE RELATED. CULTURES WERE PERFORMED, BUT THE RESULTS WERE NOT PROVIDED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND IS RECOVERING WELL POSTOPERATIVELY. THE DEVICES WERE NOT RETURNED FOR ANALYSIS, AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647049 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-3128-55B 5001141 00191506023577

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization| R