BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 24434612 · Received February 24, 2026

    Report

    Report Number
    3006630150-2026-01082
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    August 3, 2025
    Report Date
    April 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985051
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION (IN THE ABSENCE OF ALL THE PRODUCTS BEING RETURNED) BOSTON SCIENTIFIC HAS DETERMINED THAT INFECTION, DISCOMFORT, REDNESS, SWELLING, AND PURULENT DISCHARGE AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD INCISION SITES ARE A KNOWN INHERENT RISK WITH THE USE OF DEEP BRAIN STIMULATION (DBS) AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). A REVIEW OF ALL THE MANUFACTURING DOCUMENTATIONS FOR THE 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 IFU PRODUCT LABEL. ADDITIONALLY, IMPLANT SITE COMPLICATIONS SUCH AS INFECTION, DISCOMFORT, REDNESS, SWELLING, AND PURULENT DISCHARGE ARE NOTED WITHIN THE IFU AS A POTENTIAL RISK ASSOCIATED WITH THE USE OF THE DEVICE. THE IPG, LEADS AND LEAD EXTENSIONS WERE NOT RETURNED AS THEY WERE RETAINED BY THE FACILITY; AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. THE IPG, LEADS AND LEAD EXTENSIONS WERE NOT RETURNED, AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, THE LABELING REVIEW WAS CONDUCTED. THIS REVIEW DETERMINED THAT INFECTION, DISCOMFORT, REDNESS, SWELLING, AND PURULENT DISCHARGE IS A KNOWN INHERENT RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER DEEP BRAIN STIMULATION (DBS). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT/DEVICE EVALUATION: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5002143. UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5003730. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5002419. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5000915. UDI: (B)(4). BLOCK D2B ADDITIONAL PRO CODES, NHL, PJS.

    Additional Manufacturer Narrative · 0

    GOOD-FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO FURTHER DETAILS WERE AVAILABLE. BLOCK D2B ADDITIONAL PRO CODES, NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5002143, UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5003730, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5002419, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5000915, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT REPORTED DISCOMFORT, REDNESS, SWELLING, AND PURULENT DISCHARGE AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD INCISION SITES. THE PATIENT SUBSEQUENTLY UNDERWENT REMOVAL OF THE DBS SYSTEM. ACCORDING TO THE PHYSICIAN, THE INFECTION WAS NOT ATTRIBUTED TO THE DEVICE OR THE PROCEDURE, THOUGH NO ALTERNATIVE CAUSE WAS PROVIDED. DEVICE ANALYSIS WAS NOT PERFORMED AS THE COMPONENTS WERE RETAINED BY THE MEDICAL FACILITY. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND MADE A FULL RECOVERY. GOOD-FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO FURTHER DETAILS WERE AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT REPORTED DISCOMFORT, REDNESS, SWELLING, AND PURULENT DISCHARGE AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD INCISION SITES. THE PATIENT SUBSEQUENTLY UNDERWENT REMOVAL OF THE DBS SYSTEM. ACCORDING TO THE PHYSICIAN, THE INFECTION WAS NOT ATTRIBUTED TO THE DEVICE OR THE PROCEDURE, THOUGH NO ALTERNATIVE CAUSE WAS PROVIDED. DEVICE ANALYSIS WAS NOT PERFORMED AS THE COMPONENTS WERE RETAINED BY THE MEDICAL FACILITY. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309500 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1232 767639 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention