BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 24405862 · Received February 20, 2026

    Report

    Report Number
    3006630150-2026-01036
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    September 17, 2025
    Report Date
    April 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729985051
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5003317, UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5004325 UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216950, MODEL: DB-3216-95, SERIAL: (B)(6), BATCH: 5001118, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216950, MODEL: DB-3216-95, SERIAL: (B)(6), BATCH: 5001125, UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: NA, BATCH: 36866657, UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: NA, BATCH: 36686668, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    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. PHYSICAL ANALYSIS COULD NOT BE COMPLETED IN OUR LABORATORY, AS THE DEVICES WERE DISPOSED BY THE MEDICAL FACILITY AND WERE NOT RETURNED. 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). ADDITIONALLY, LABELING STATES THAT THE BOSTON SCIENTIFIC DBS SYSTEM IS INDICATED FOR USE IN THE FOLLOWING: BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) AS AN ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF MODERATE TO ADVANCED LEVODOPA RESPONSIVE PARKINSONS DISEASE (PD) THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION. BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) AS AN ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED LEVODOPA RESPONSIVE PARKINSONS DISEASE (PD) THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION. UNILATERAL THALAMIC STIMULATION OF THE VENTRAL INTERMEDIATE NUCLEUS (VIM) IS INDICATED FOR THE SUPPRESSION OF TREMOR IN THE UPPER EXTREMITY. THE SYSTEM IS INTENDED FOR USE IN PATIENTS WHO ARE DIAGNOSED WITH ESSENTIAL TREMOR OR PARKINSONIAN TREMOR NOT ADEQUATELY CONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY. BILATERAL STIMULATION OF THE VENTRAL INTERMEDIATE NUCLEUS (VIM) OF THE THALAMUS FOR THE SUPPRESSION OF DISABLING UPPER EXTREMITY TREMOR IN ADULT ESSENTIAL TREMOR PATIENTS WHOSE TREMOR IS NOT ADEQUATELY CONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY. THE DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED 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). ADDITIONALLY, IT WAS REPORTED THAT THE DBS SYSTEM WAS IMPLANTED FOR DYSTONIA, WHICH IS NOT LISTED AS AN APPROVED INDICATION FOR USE OF THE DBS SYSTEM AND IS CONSIDERED AN INTENTIONAL OFF LABEL, UNAPPROVED, OR CONTRAINDICATED USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION NEAR THE RIGHT CHEST OVER THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY AND WERE NOT RETURNED. A CULTURE WAS TAKEN BUT THE RESULTS WERE NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION NEAR THE RIGHT CHEST OVER THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY AND WERE NOT RETURNED. A CULTURE WAS TAKEN BUT THE RESULTS WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62092 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1232 796775 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention