BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERCISE CARTESIA

    MDR report key: 10310094 · Received July 22, 2020

    Report

    Report Number
    3006630150-2020-03035
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 9, 2020
    Report Date
    September 2, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905271
    PMA / PMN Number
    P150031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RETURNED LEADS REVEALED THAT THE LEADS ARE SLIGHTLY CURVED. HOWEVER, THE DISTAL END STRAIGHTNESS SPECIFICATION WAS CHECKED, AND THE RETURNED LEADS WERE CONFIRMED TO BE STILL WITHIN THE SPECIFICATION. THE LEADS HAVE A DISPLACEMENT OF LESS THAN 1.3 MM RELATIVE TO THE VERTICAL. BASED ON THE PROVIDED INFORMATION, THE INVESTIGATION CONCLUDED THAT ALTHOUGH THE DISTAL TIPS OF THE LEADS ARE SLIGHTLY CURVED THE LEADS REMAIN WITHIN THE SPECIFICATION. THEREFORE, A PROBABLE CAUSE CANNOT BE DETERMINED AS NO PROBLEM HAS BEEN DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN NOTICED A SMALL CURVATURE AT THE TIP OF THE LEAD RESULTING IN THE ELECTRODE CHANGING TRAJECTORY THROUGH THE BRAIN. THE LEAD WAS REMOVED AND ANOTHER TWO LEADS WERE USED BUT THE SAME ISSUE WAS APPARENT ON BOTH LEADS. ALL LEADS WERE REMOVED AND THE PROCEDURE WAS CANCELLED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7071022 AND 7071037.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN NOTICED A SMALL CURVATURE AT THE TIP OF THE LEAD RESULTING IN THE ELECTRODE CHANGING TRAJECTORY THROUGH THE BRAIN. THE LEAD WAS REMOVED AND ANOTHER TWO LEADS WERE USED BUT THE SAME ISSUE WAS APPARENT ON BOTH LEADS. ALL LEADS WERE REMOVED AND THE PROCEDURE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773379 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-30 7071004 08714729905271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other