BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    MDR report key: 24565451 · Received March 10, 2026

    Report

    Report Number
    3006630150-2026-01409
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    January 29, 2026
    Report Date
    April 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729966340
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-2203-45, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: (B)(6), MODEL/CATALOG DESCRIPTION: ARGYLE LEAD 45CM STERILE KIT, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED AS THEY REMAIN IMPLANTED IN THE PATIENT. AS SUCH, PHYSICAL ANALYSIS WAS UNABLE TO BE PERFORMED. HOWEVER, IT WAS CONFIRMED THE DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT INTRACRANIAL HEMORRHAGE IS A KNOWN RISK ASSOCIATED WITH USE OF DBS. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-2203-45 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5005974 MODEL/CATALOG DESCRIPTION: ARGYLE LEAD 45CM STERILE KIT UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A RIGHT SIDED BRAIN BLEED FOLLOWING THE DBS IMPLANT PROCEDURE. THEREFORE, THE PATIENT WAS HOSPITALIZED. THE PATIENT IS DOING WELL AND IS EXPECTED TO FULLY RECOVER. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A RIGHT SIDED BRAIN BLEED FOLLOWING THE DBS IMPLANT PROCEDURE. THEREFORE, THE PATIENT WAS HOSPITALIZED. THE PATIENT IS DOING WELL AND IS EXPECTED TO FULLY RECOVER. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380833 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2203-45 5006048 08714729966340

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization