BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 15584457 · Received October 11, 2022

    Report

    Report Number
    3006630150-2022-05471
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    August 13, 2021
    Report Date
    November 14, 2022
    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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7082132.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7082132.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE THERAPY. REPROGRAMMING ATTEMPTS DID NOT IMPROVE THE PATIENTS THERAPY. THE PHYSICIAN ASSESSED THAT THE ORIGINAL LEAD PLACEMENT WAS TOO LATERAL FOR OPTIMAL THERAPEUTIC BENEFIT. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE BOTH LEADS WERE EXPLANTED AND REPLACED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE THERAPY. REPROGRAMMING ATTEMPTS DID NOT IMPROVE THE PATIENTS THERAPY. THE PHYSICIAN ASSESSED THAT THE ORIGINAL LEAD PLACEMENT WAS TOO LATERAL FOR OPTIMAL THERAPEUTIC BENEFIT. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE BOTH LEADS WERE EXPLANTED AND REPLACED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL AND RECEIVED THERAPEUTIC BENEFIT FROM THE DBS SYSTEM POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2880035 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7079916 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention