BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 12437128 · Received September 7, 2021

    Report

    Report Number
    3006630150-2021-05008
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    September 21, 2020
    Report Date
    September 7, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB-4600C0, MODEL: DB-4600-C, SERIAL: N/A, LOT: 23746158. PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB1200S0, MODEL: DB-1200-S, SERIAL: (B)(4), LOT: 737133. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3136550, MODEL: NM-3136-55 , SERIAL: (B)(4), LOT: 7040494. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3136550, MODEL: NM-3136-55, SERIAL: (B)(4), LOT: 7041441. PRODUCT FAMILY: DBS-LINEAR LEADS (LEFT LEAD), UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), LOT: 5156024.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ONGOING INFECTION AT THE DEEP BRAIN STIMULATION DBS LEAD SITE, BURR HOLE SITE, AND IMPLANTABLE PULSE GENERATOR IPG SITE. THE PATIENT HAD BEEN ADMINISTERED IV ANTIBIOTICS, HOWEVER, THE INFECTION DID NOT RESOLVE AND DEHISCENCE DEVELOPED, EXPOSING THE RIGHT LEAD. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICES BUT THE LEFT LEAD AND LEFT BURR HOLE COVER WERE REMOVED. POST-OPERATIVELY, THE PATIENT IS DOING AS EXPECTED. THE DEVICES REMAIN AT THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333898 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 5156045 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention