BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 20762111 · Received November 22, 2024

    Report

    Report Number
    3006630150-2024-08087
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    January 17, 2024
    Report Date
    November 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODES: NHL, PJS. BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED BETWEEN 17JAN2024 AND 03MAR2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7119556, PRODUCT FAMILY: DBS-IPG-PC, UPN: M365DB14080, MODEL: DB-1408, SERIAL: (B)(6), BATCH: 220256, PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: N/A, BATCH: 32891466.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODES: NHL, PJS. BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED BETWEEN 17JAN2024 AND 03MAR2024. CORRECTION TO THE INITIAL MDR IN BLOCK H6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE, AND THEIR LEAD WAS EXPOSED IN ADDITION TO AN INFECTION HOWEVER THE LOCATION OF THE INFECTION IS UNKNOWN. IT WAS NOTED THAT THE PATIENT'S CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) MASK CAUSED THE DBS LEAD TO BE EXPOSED PER THE PHYSICIAN'S ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE WHOLE DBS SYSTEM WAS REMOVED. PHYSICAL ANALYSIS OF THE DBS DEVICES WAS NOT PERFORMED AS THEY WERE DISPOSED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE, AND THEIR LEAD WAS EXPOSED IN ADDITION TO AN INFECTION HOWEVER THE LOCATION OF THE INFECTION IS UNKNOWN. IT WAS NOTED THAT THE PATIENTS CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) MASK CAUSED THE DBS LEAD TO BE EXPOSED PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE WHOLE DBS SYSTEM WAS REMOVED. PHYSICAL ANALYSIS OF THE DBS DEVICES WAS NOT PERFORMED AS THEY WERE DISPOSED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY. ADDITIONAL INFORMATION RECEIVED STATED THAT THE DBS PATIENT EXPERIENCED REDNESS, INFLAMMATION, SKIN BREAKDOWN AND AN INFECTION AT THE CRANIAL INCISION SITE. THE PATIENT WAS PRESCRIBED ANTI-BIOTICS HOWEVER NO CULTURE WAS TAKEN. THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777830 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7113608 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention