BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 23824067 · Received December 16, 2025

    Report

    Report Number
    3006630150-2025-11491
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729966395
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B5 DESCRIBE EVENT OR PROBLEM UPDATED. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS NOT BEEN PROVIDED BY THE FACILITY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5002888. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS NOT BEEN PROVIDED BY THE FACILITY. BLOCK B3: DATE OF EVENT UNKNOWN, APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5002888, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT PRESENTED WITH DEHISCENCE AT THE LEAD EXTENSION INCISION SITE BEHIND THE EAR. IT WAS NOTED THAT THE INCISION WAS NOT HEALING PROPERLY. THE PATIENT UNDERWENT INTERVENTION WHEREIN THE INCISION SITE WAS CLEANED WITH IODINE AND TREATED WITH ANTIBIOTICS BEFORE COMPLETING THE PROCEDURE. THE LEAD EXTENSIONS REMAIN IMPLANTED. IT IS UNCLEAR WHETHER CULTURES WERE OBTAINED. THE PATIENT WAS PLACED ON A REGIMEN OF STEROIDS AND ANTIBIOTICS AND HAS SINCE DEVELOPED A SCAB. ONGOING CARE IS BEING PROVIDED BY THE TREATING PHYSICIAN. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED PAIN AND PURULENT DISCHARGE AT THE INCISION SITE. THE PATIENT IS DOING WELL AND WOUND HAS SINCE THEN CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT PRESENTED WITH DEHISCENCE AT THE LEAD EXTENSION INCISION SITE BEHIND THE EAR. IT WAS NOTED THAT THE INCISION WAS NOT HEALING PROPERLY. THE PATIENT UNDERWENT INTERVENTION WHEREIN THE INCISION SITE WAS CLEANED WITH IODINE AND TREATED WITH ANTIBIOTICS BEFORE COMPLETING THE PROCEDURE. THE LEAD EXTENSIONS REMAIN IMPLANTED. THE PATIENT WAS PLACED ON A REGIMEN OF STEROIDS AND ANTIBIOTICS AND HAS SINCE DEVELOPED A SCAB. ONGOING CARE IS BEING PROVIDED BY THE TREATING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75165 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-3216-55 5002885 08714729966395

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention