BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    MDR report key: 24341215 · Received February 14, 2026

    Report

    Report Number
    3006630150-2026-00902
    Event Type
    Injury
    Date Received
    February 14, 2026
    Date of Event
    January 21, 2026
    Report Date
    April 3, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729966340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-2203-45. SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5003773, 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: 5002733; 5002748, MODEL/CATALOG DESCRIPTION: ARGYLE EXTENSION 55CM STERILE KIT, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-4600-C, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 36814214, MODEL/CATALOG DESCRIPTION: SURETEK BURR HOLE COVER KIT, UNIQUE IDENTIFIER (UDI) # (B)(4). WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE CAUSE OF THE PATIENT EXPERIENCING EDEMA AND A SUSPECTED INFECTION AND UNDERGOING A PROCEDURE IN WHICH THE IPG POCKET WAS IRRIGATED, WAS CONFIRMED BASED ON RECORD REVIEW. A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THE DEVICE INDICATED THAT IT WAS SUCCESSFULLY PROCESSED ACCORDING TO REQUIREMENTS. THE DEVICE HISTORY REVIEW, DHR, DID NOT IDENTIFY ANY MANUFACTURING PROCESS-RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING PRODUCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE DHR REVIEW ENSURES EACH DEVICE MEETS REQUIRED SPECIFICATIONS AND ASSOCIATED TESTING PRIOR TO RELEASE FOR DISTRIBUTION/SALE. THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW WAS PERFORMED ON THE DEVICES' INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE DEVICES WERE NOT RETURNED AS SUCH PHYSICAL ANALYSIS WAS NOT CONDUCTED, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS ABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THE COMPLAINT, AND THE CONCLUSION IS KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-2203-45, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5003773, 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: 5002733; 5002748, MODEL/CATALOG DESCRIPTION: ARGYLE EXTENSION 55CM STERILE KIT, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-4600-C, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 36814214, MODEL/CATALOG DESCRIPTION: SURETEK BURR HOLE COVER KIT, UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION WITH REDNESS AT THE LEAD SITE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT WAS REFERRED TO EMERGENCY ROOM DEPARTMENT (ER), WAS SUBSEQUENTLY ADMITTED AND UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE DEVICES WERE EXPLANTED, THE AREA WAS WASHED OUT WITH SALINE INFUSED ANTIBIOTICS AND IS UNDERGOING TREATMENT TO RESOLVE THE INFECTION. CULTURES WERE TAKEN AND WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT WAS DISCHARGED AND IS RECOVERING WELL. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION WITH REDNESS AT THE LEAD SITE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE DEVICES WERE EXPLANTED, THE AREA WAS WASHED OUT WITH SALINE INFUSED ANTIBIOTICS AND IS UNDERGOING TREATMENT TO RESOLVE THE INFECTION. CULTURES WERE TAKEN AND WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT WAS DISCHARGED AND IS RECOVERING WELL. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401877 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2203-45 5003783 08714729966340

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention