BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    MDR report key: 24352005 · Received February 16, 2026

    Report

    Report Number
    3006630150-2026-00925
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 22, 2026
    Report Date
    April 6, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY WERE RETAINED BY THE CUSTOMER. AS SUCH, PHYSICAL ANALYSIS WAS UNABLE TO BE PERFORMED. HOWEVER, IT WAS CONFIRMED THESE DEVICES MET MANUFACTURING SPECIFICATION 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 IMPLANT SITE COMPLICATIONS SUCH AS PAIN, POOR HEALING, REDNESS, WARMTH, SWELLING OR WOUND REOPENING AS WELL AS INFECTION ARE KNOWN RISKS 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. BLOCK B3: EXACT DATE UNKNOWN, BASED OFF BSC AWARE DATE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-2203-45. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5002075. MODEL/CATALOG DESCRIPTION: ARGYLE LEAD 45CM STERILE KIT. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-3216-55. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5002211. MODEL/CATALOG DESCRIPTION: ARGYLE EXTENSION 55CM STERILE KIT. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-3216-55. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5002208. MODEL/CATALOG DESCRIPTION: ARGYLE EXTENSION 55CM STERILE KIT. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-1232. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 795508. MODEL/CATALOG DESCRIPTION: VERCISE GENUS R32 IPG KIT. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, BASED OFF BSC AWARE DATE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: UPN: M365DB2203450 MODEL: DB-2203-45 SERIAL: (B)(6). BATCH: 5002075 UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB3216550 MODEL: DB-3216-55 SERIAL: (B)(6). BATCH: 5002208 UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB3216550 MODEL: DB-3216-55 SERIAL: (B)(6). BATCH: 5002211 UDI: (B)(4). PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12320 MODEL: DB-1232 SERIAL: (B)(6). BATCH: 795508 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE AT THE LEAD/LEAD EXTENSION SITE WHERE A LEAD HAD PROTRUDED THROUGH THE SKIN. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THEIR DBS SYSTEM AND A CULTURE WAS TAKEN INTRAOPERATIVELY. DUE TO HOSPITAL POLICY, THE CULTURE RESULTS WERE UNABLE TO BE DISCLOSED TO BSC. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY AND THE PATIENT WAS PLACED ON ANTIBIOTIC MEDICATION. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE AT THE LEAD/LEAD EXTENSION SITE WHERE A LEAD HAD PROTRUDED THROUGH THE SKIN. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THEIR DBS SYSTEM AND A CULTURE WAS TAKEN INTRAOPERATIVELY. DUE TO HOSPITAL POLICY, THE CULTURE RESULTS WERE UNABLE TO BE DISCLOSED TO BSC. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY AND THE PATIENT WAS PLACED ON ANTIBIOTIC MEDICATION. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412797 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2203-45 5002665 08714729966340

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention