BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 20502005 · Received October 22, 2024

    Report

    Report Number
    3006630150-2024-07183
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    May 8, 2024
    Report Date
    October 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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-IPG-R-MRI; UPN: M365DB12160; MODEL: DB-1216; BATCH/SERIAL: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; BATCH/SERIAL: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; BATCH/SERIAL: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; BATCH/SERIAL: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; BATCH/SERIAL: (B)(6). PRODUCT FAMILY: DBS-EXTENSION; UPN: M365DB312855B0; MODEL: DB-3128-55B; BATCH/SERIAL: (B)(6). PRODUCT FAMILY: DBS-EXTENSION; UPN: M365DB312855B0; MODEL: DB-3128-55B; BATCH/SERIAL: (B)(6). PRODUCT FAMILY: DBS-LEAD FIXATION; UPN: M365DB4600C0; MODEL: DB-4600C; BATCH: 33133630. PRODUCT FAMILY: DBS-LEAD FIXATION; UPN: M365DB4600C0; MODEL: DB-4600C; BATCH: 33572843.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED REDNESS AND SWELLING NEAR THEIR INCISION SITE. IT WAS ASSESSED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE INCISION SITE. THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT, WAS ADMINISTERED MEDICATION, AND IS DOING WELL POSTOPERATIVELY. THE MEDICAL FACILITY DISCARDED THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300889 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 586318 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention