BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 18608991 · Received January 30, 2024

    Report

    Report Number
    3006630150-2024-00356
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    December 22, 2023
    Report Date
    July 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 7102651. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7119303. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7119568. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0, MODEL: DB-4600C, BATCH: 32118920. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0, MODEL: DB-4600C, BATCH: 32118920. PRODUCT FAMILY: DBS-IPG-R-MRI: UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 576276.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 32118920.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED THE SCAB AT THE INCISION SITE OF THE RIGHT BURR HOLE COVER HAD COME OFF AND THE LEAD BECAME EXPOSED THROUGH THE INCISION SITE. THE PATIENT EXPERIENCED PAIN AND TINGLING. A CULTURE WAS PERFORMED AT THE BURR HOLE COVER SITE AND CAME BACK POSITIVE FOR PSEUDOMONAS INFECTION. THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE AND WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING WELL POST-OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENTS WOUND WAS STILL NOT HEALING PROPERLY AND THERE WAS CONFIRMATION OF PSEUDOMONAS INFECTION PRESENT AT THE SITE OF LEAD AND EXTENSION CONNECTOR. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE FULL SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE EXPLANTED DEVICES WERE DISCARDED 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 THE SCAB AT THE INCISION SITE OF THE RIGHT BURR HOLE COVER HAD COME OFF AND THE LEAD BECAME EXPOSED THROUGH THE INCISION SITE. THE PATIENT EXPERIENCED PAIN AND TINGLING. A CULTURE WAS PERFORMED AT THE BURR HOLE COVER SITE AND CAME BACK POSITIVE FOR PSEUDOMONAS INFECTION. THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE AND WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250234 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7102667 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention