BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 18866421 · Received March 8, 2024

    Report

    Report Number
    3006630150-2024-01337
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 19, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 7106454; PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 7106591.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7112609. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7112679. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A . BATCH: 32803889. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A . BATCH: 32445505.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A STAPH INFECTION AT BOTH THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND THE LEAD AND LEAD EXTENSION SITES WHEREIN SHOWING SIGNS OF REDNESS. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WERE NOT RETURNED TO BSC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A STAPH INFECTION AT BOTH THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND THE LEAD AND LEAD EXTENSION SITES WHEREIN SHOWING SIGNS OF REDNESS. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WERE NOT RETURNED TO BSC. ADDITIONAL INFORMATION WAS RECEIVED PROVIDING THE MODEL AND SERIAL NUMBER OF THE LEADS AND BURR HOLE COVERS THAT WERE ALSO EXPLANTED DURING THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170150 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 588707 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention