BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 18847612 · Received March 6, 2024

    Report

    Report Number
    3006630150-2024-01245
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    August 1, 2023
    Report Date
    March 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: 7070771; PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 5174899; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7070057; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7071689.

    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: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A STAPH INFECTION IN THE HEAD AREA. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE FULL DBS SYSTEM WAS REMOVED. DESPITE MULTIPLE GOOD FAITH EFFORTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A STAPH INFECTION IN THE HEAD AREA. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE FULL DBS SYSTEM WAS REMOVED. DESPITE MULTIPLE GOOD FAITH EFFORTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION REGARDING THIS ADVERSE EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN ASSESSED THE INFECTION WAS CAUSED BY A TREE LIMB HITTING THE PATIENT ON THE TOP OF THE HEAD AND DOESN'T BELIEVE IT TO BE CAUSED BY THE DEVICE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND WAS DOING WELL POST-OPERATIVELY. THE FACILITY NAME OF WHERE THE REVISION PROCEDURE TOOK PLACE WAS ALSO PROVIDED. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110481 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 741279 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention