BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 24492425 · Received March 2, 2026

    Report

    Report Number
    3006630150-2026-01215
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    October 22, 2025
    Report Date
    April 9, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-3216-55 SERIAL NUMBER:(B)(6) BATCH/LOT NUMBER: 5003816 AND 5003683 MODEL/CATALOG DESCRIPTION: ARGYLE EXTENSION 55CM STERILE KIT UNIQUE IDENTIFIER (UDI) # (B)(4). WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE CAUSE OF THE PATIENT EXPERIENCING IMPAIRED HEALING, AN INFECTION, BEING HOSPITALIZED AND UNDERGOING A PROCEDURE IN WHICH THE IPG AND LEAD EXTENSION WERE EXPLANTED, 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 DEVICES WERE DISCARDED BY THE FACILITY AND 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. IT STATES INFECTION AND IMPLANT SITE COMPLICATIONS SUCH AS PAIN, POOR HEALING, REDNESS, WARMTH, SWELLING OR WOUND REOPENING ARE A KNOWN RISKS WITH THE USE OF DEEP BRAIN STIMULATION. 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 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 AS KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-3216-55 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5003816 AND 5003683 MODEL/CATALOG DESCRIPTION: ARGYLE EXTENSION 55CM STERILE KIT UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS' IMPLANTABLE PULSE GENERATOR (IPG) INCISION SITE, ON THEIR CHEST, OF THE DEEP BRAIN STIMULATION (DBS) DID NOT HEAL ADEQUATELY AND DEVELOPED AN INFECTION, THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS HOSPITALIZED, UNDERWENT AN EXPLANT OF THE (IPG) AND THE LEAD EXTENSIONS, CULTURES WERE TAKEN, HOWEVER, THE RESULTS ARE UNKNOWN, AND THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS' IMPLANTABLE PULSE GENERATOR (IPG) INCISION SITE, ON THEIR CHEST, OF THE DEEP BRAIN STIMULATION (DBS) DID NOT HEAL ADEQUATELY AND DEVELOPED AN INFECTION, THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS HOSPITALIZED, UNDERWENT AN EXPLANT OF THE (IPG) AND THE LEAD EXTENSIONS, CULTURES WERE TAKEN, HOWEVER, THE RESULTS ARE UNKNOWN, AND THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553160 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1232 801365 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| H