BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 10199040 · Received June 26, 2020

    Report

    Report Number
    3006630150-2020-02642
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    June 5, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6); LOT: 7070889.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOUR DAYS AFTER A LEAD IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A STROKE AND EXHIBITED VERBAL DEFICIENCIES. THE PHYSICIAN ASSESSED THE EVENT WAS DUE TO THE PATIENT HAVING STOPPED TAKING BLOOD THINNERS PRIOR TO THE PROCEDURE. THE LEADS REMAIN IN SITU AND THE PATIENT WILL UNDERGO REHABILITATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS SOME VERBAL ISSUES AND ONE SIDED WEAKNESS. SHE IS CURRENTLY IN REHABILITATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), LOT :7070889.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR DAYS AFTER A LEAD IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A STROKE AND EXHIBITED VERBAL DEFICIENCIES. THE PHYSICIAN ASSESSED THE EVENT WAS DUE TO THE PATIENT HAVING STOPPED TAKING BLOOD THINNERS PRIOR TO THE PROCEDURE. THE LEADS WERE LEFT IN SITU AND THE PATIENT WILL UNDERGO REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662828 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7070008 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other