BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 20100316 · Received August 29, 2024

    Report

    Report Number
    3006630150-2024-05746
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: 7122553. PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 599240. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7126603. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7127416. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: (B)(6), BATCH: 34009175. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: (B)(6), BATCH: 34009175.

    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: 7122553. PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 599240. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7126603. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7127416. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: NULL, BATCH: 34009175. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: NULL, BATCH: 34009175.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION OF THE WHOLE SYSTEM. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE LEADS, IMPLANTABLE PULSE GENERATOR (IPG), LEAD EXTENSIONS, AND BURR HOLE COVERS WERE REMOVED. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE HOSPITAL AND WERE NOT RETURNED TO BSC. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE INFECTION THE PATIENT EXPERIENCED WAS A STAPH INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION OF THE WHOLE SYSTEM. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE LEADS, IMPLANTABLE PULSE GENERATOR (IPG), LEAD EXTENSIONS, AND BURR HOLE COVERS WERE REMOVED. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE HOSPITAL AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354720 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7121558 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention