BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    MDR report key: 24153187 · Received January 22, 2026

    Report

    Report Number
    3006630150-2026-00473
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    December 27, 2025
    Report Date
    March 19, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THESE DEVICES INDICATED THAT THEY WERE SUCCESSFULLY PROCESSED ACCORDING TO REQUIREMENTS. THE 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. LABELING REVIEW: A LABELLING REVIEW WAS PERFORMED, AND IT DID NOT REVEAL ANY ANOMALIES AS IT STATES INFECTION IS A KNOWN RISK WITH THE USE OF DEEP BRAIN STIMULATION (DBS). INVESTIGATION CONCLUSION: THE DEVICES WERE NOT RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, A LABELING REVIEW WAS CONDUCTED. THIS REVIEW DETERMINED THE REPORTED EVENT OF INFECTION IS A KNOWN RISK ASSOCIATED WITH THE USE OF DEEP BRAIN STIMULATION (DBS) AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Additional Manufacturer Narrative · 0

    BLOCK B3 DATE OF EVENT: APPROXIMATELY ONE WEEK BEFORE PATIENTS VISIT TO HOSPITAL - EXACT EVENT DATE IS UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5003972. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5004007. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) EXPERIENCED AN INFECTION AT THE SITE OF THE LEAD. THE PATIENT WENT TO THE HOSPITAL AND UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED. A CULTURE WAS TAKEN AND RESULTS WERE NEGATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) EXPERIENCED AN INFECTION AT THE SITE OF THE LEAD. THE PATIENT WENT TO THE HOSPITAL AND UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED. A CULTURE WAS TAKEN AND RESULTS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213582 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2203-45 5005233 08714729966340

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention| H