BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 15322905 · Received August 30, 2022

    Report

    Report Number
    3006630150-2022-04366
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 6, 2022
    Report Date
    June 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(4); LOT: 7088114. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(4); LOT: 7088410.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), LOT: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), LOT: (B)(6). PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), LOT: (B)(6). PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), LOT: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND THEREFORE, UNDERWENT A DEEP BRAIN STIMULATION SYSTEM EXPLANT PROCEDURE. THE INFECTION WAS NOT CONSIDERED TO BE DEVICE RELATED, HOWEVER, NO FURTHER INFORMATION REGARDING THIS EVENT WAS OBTAINED DESPITE THREE GOOD FAITH EFFORTS. THE DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND THEREFORE, UNDERWENT A DEEP BRAIN STIMULATION SYSTEM EXPLANT PROCEDURE. THE INFECTION WAS NOT CONSIDERED TO BE DEVICE RELATED, HOWEVER, NO FURTHER INFORMATION REGARDING THIS EVENT WAS OBTAINED DESPITE THREE GOOD FAITH EFFORTS. THE DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135512 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 529276 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention