BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 22116738 · Received May 30, 2025

    Report

    Report Number
    3006630150-2025-03808
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    April 8, 2025
    Report Date
    September 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7073557, UDI: (B)(4). PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7075302, UDI: (B)(4). PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7073352, UDI: (B)(4). PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7075303, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS UPN: M365DB9218150 MODEL: DB-9218-15 SERIAL: (B)(6) BATCH: 7073557 UDI: (B)(4). PRODUCT FAMILY: DBS-ADAPTERS UPN: M365DB9218150 MODEL: DB-9218-15 SERIAL: (B)(6) BATCH: 7075302 UDI: (B)(4). PRODUCT FAMILY: DBS-ADAPTERS UPN: M365DB9218150 MODEL: DB-9218-15 SERIAL: (B)(6) BATCH: 7073352 UDI: (B)(4). PRODUCT FAMILY: DBS-ADAPTERS UPN: M365DB9218150 MODEL: DB-9218-15 SERIAL: (B)(6) BATCH: 7075303 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED MODERATE WORSENING OF PARKINSON'S SYMPTOMS WITH RIGIDITY AND BRADYKINESIA ON THE LEFT SIDE DUE TO INADEQUATE STIMULATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) AND ADAPTERS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS REPORTED AS RELATED TO THE STIMULATION AND NOT RELATED TO THE PROCEDURE OR DEVICE HARDWARE. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED MODERATE WORSENING OF PARKINSON'S SYMPTOMS WITH RIGIDITY AND BRADYKINESIA ON THE LEFT SIDE DUE TO INADEQUATE STIMULATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) AND ADAPTERS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS REPORTED AS RELATED TO THE STIMULATION AND NOT RELATED TO THE PROCEDURE OR DEVICE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667886 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 539959 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H