BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 14836489 · Received June 27, 2022

    Report

    Report Number
    3006630150-2022-03123
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    December 8, 2021
    Report Date
    June 27, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: 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: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(4); BATCH: 7091276. PRODUCT FAMILY: DBS-LEAD FIXATION; UPN: M365DB4600C0; MODEL: DB-4600C; SERIAL: N/A; BATCH: 27845134. PRODUCT FAMILY: DBS-LEAD FIXATION; UPN: M365DB4600C0; MODEL: DB-4600C; SERIAL: N/A; BATCH: 27889855. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(4); BATCH: 7091321. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202300; MODEL: DB-2202-30; SERIAL: (B)(4); BATCH: 7075765. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202300; MODEL: DB-2202-30; SERIAL: (B)(4); BATCH: 7075501.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED SKIN REDNESS AND ITCHING IN CHANGING BODY REGIONS SHORTLY AFTER BEING IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PHYSICIAN ASSESSED THE PATIENT HAD AN ALLERGIC REACTION TO THE IMPLANTED DEVICE BASED ON THE TEMPORAL CONNECTION. THE PATIENT WAS HOSPITALIZED AND PRESCRIBED ANTI-HISTAMINE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939014 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 524125 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention