BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 24282973 · Received February 6, 2026

    Report

    Report Number
    3006630150-2026-00759
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 30, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITH ALL THE AVAILABLE INFORMATION (IN THE ABSENCE OF PRODUCT RETURN), BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF DEHISCENCE, EROSION AND INFECTION IS A KNOWN INHERENT RISK AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR ALL THE DBS DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. ADDITIONALLY, LABELING STATES THAT DEHISCENCE, EROSION AND INFECTION IS A KNOWN INHERENT RISK AS DOCUMENTED IN THE IFU OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER DEEP BRAIN STIMULATION (DBS). THE DBS DEVICES WERE ALL RETAINED BY THE FACILITY. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, THE LABELING REVIEW WAS CONDUCTED. WITH THE REPORTED OBSERVATIONS AND THE LABELING REVIEW, IT HAS BEEN DETERMINED THAT DEHISCENCE, EROSION AND INFECTION IS A KNOWN INHERENT RISK WITH USE OF THE DEVICES AS DOCUMENTED IN THE IFU. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5003102. UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5003345. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5001802. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5001865. UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: N/A. BATCH: 35765308. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5003102. UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5003345. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5001802. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5001865. UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: N/A. BATCH: 35765308. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION LEADING TO DEHISCENCE AT THE IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT SITE. THE PHYSICIAN BELIEVED THE AREA WAS INFECTED, THOUGH THE INFECTION WAS NOT CONSIDERED RELATED TO THE DEVICE OR THE PROCEDURE. IT IS UNKNOWN WHETHER CULTURES WERE OBTAINED. THE PATIENT SUBSEQUENTLY UNDERWENT COMPLETE EXPLANTATION OF THE DBS SYSTEM BEFORE COMPLETING THE PROCEDURE. ANALYSIS OF THE DEVICES WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION LEADING TO DEHISCENCE AT THE IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT SITE. THE PHYSICIAN BELIEVED THE AREA WAS INFECTED, THOUGH THE INFECTION WAS NOT CONSIDERED RELATED TO THE DEVICE OR THE PROCEDURE. IT IS UNKNOWN WHETHER CULTURES WERE OBTAINED. THE PATIENT SUBSEQUENTLY UNDERWENT COMPLETE EXPLANTATION OF THE DBS SYSTEM BEFORE COMPLETING THE PROCEDURE. ANALYSIS OF THE DEVICES WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544663 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1232 780253 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention