BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 19255970 · Received May 6, 2024

    Report

    Report Number
    3006630150-2024-02908
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    February 17, 2022
    Report Date
    June 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(4). BATCH: 513162. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202300. MODEL: DB-2202-30. SERIAL: (B)(4). BATCH: 7075770. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202300. MODEL: DB-2202-30. SERIAL: (B)(4). BATCH: 7076058. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55 . SERIAL: (B)(4). BATCH: 7088233. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550.. MODEL: NM-3138-55 . SERIAL: (B)(4). BATCH: 7088274. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 28262140.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(6). BATCH: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300. MODEL: DB-2202-30. SERIAL: (B)(6). BATCH: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300. MODEL: DB-2202-30. SERIAL: (B)(6). BATCH: (B)(6). PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550. MODEL: NM-3138-55 . SERIAL: (B)(6) . BATCH: (B)(6). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55 . SERIAL: (B)(6). BATCH: (B)(6). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 28262140.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A SYSTEM EXPLANT DUE TO NOT BEING ABLE TO ADEQUATELY COVER THE PATIENTS PEDIATRIC DYSTONIA. THE PATIENT WILL BE RE-IMPLANTED AT A LATER TIME. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS IMPLANTED TO TREAT PEDIATRIC GENETIC DYSTONIA. PATIENT INDICATED NEVER EXPERIENCING A GREAT THERAPEUTIC EFFECT FROM THE DBS SYSTEM. THE LEADS WERE WELL PLACED BUT THE PHYSICIAN DECIDED TO MOVE THE LEAD TARGET. THE EXPLANTED PRODUCT WAS RETAINED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A SYSTEM EXPLANT DUE TO NOT BEING ABLE TO ADEQUATELY COVER THE PATIENTS PEDIATRIC DYSTONIA. THE PATIENT WILL BE RE-IMPLANTED AT A LATER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388067 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 512205 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Required Intervention