BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 9993741 · Received April 23, 2020

    Report

    Report Number
    3006630150-2020-01883
    Event Type
    Injury
    Date Received
    April 23, 2020
    Date of Event
    March 30, 2020
    Report Date
    May 6, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300. MODEL: DB-2202-30. SERIAL: (B)(6). BATCH: 7070147.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT, WHO IS A PART OF THE (B)(6) VERCISE DBS REGISTRY CLINICAL STUDY, WAS ADMITTED TO THE HOSPITAL AND THREE DAYS LATER UNDERWENT AN EXPLANT OF THE LEFT AND RIGHT BRAIN LEADS. THE PATIENT WAS DISCHARGED SEVEN DAYS LATER. THE EVENT WAS REPORTED HAS HAVING A POSSIBLE RELATIONSHIP TO THE HARDWARE AND PROCEDURE. THE EVENT AND THE PATIENT ARE RECOVERING. THE PATIENTS BIRTH YEAR IS 1950, THE EXACT DATE IS UNKNOWN. THE MODEL NUMBERS OF THE DEVICES ARE UNKNOWN. ANSM REFERENCE NUMBER DIRECT DBS (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT IT HAS NOW BEEN CONFIRMED THAT THE REASON FOR THE EXPLANT OF THE LEADS WAS NOT DUE TO A MALFUNCTION NOR A SERIOUS INJURY, THE FACILITY ELECTED TO EXPLANT THE DEVICES. ALONG WITH THE LEADS THE PORTION OF THE LEAD EXTENSION SEGMENTS THAT WERE STILL CONNECTED TO THE LEADS WERE EXPLANTED. THE MODEL NUMBER OF THE DEVICES WAS RECEIVED AND REPORTED THAT THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS BY THE FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: UNK-P-DBS-LINEAR_LEADS, MODEL: UNKNOWN, SERIAL: (B)(4), BATCH: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT, WHO IS A PART OF THE (B)(6) CLINICAL STUDY, WAS ADMITTED TO THE HOSPITAL AND THREE DAYS LATER UNDERWENT AN EXPLANT OF THE LEFT AND RIGHT BRAIN LEADS. THE PATIENT WAS DISCHARGED SEVEN DAYS LATER. THE EVENT WAS REPORTED HAS HAVING A POSSIBLE RELATIONSHIP TO THE HARDWARE AND PROCEDURE. THE EVENT AND THE PATIENT ARE RECOVERING. THE PATIENTS BIRTH YEAR IS (B)(6), THE EXACT DATE IS UNKNOWN. THE MODEL NUMBERS OF THE DEVICES ARE UNKNOWN. (B)(6) REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455236 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-30 7070144

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R