BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 12451457 · Received September 9, 2021

    Report

    Report Number
    3006630150-2021-05075
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    July 16, 2021
    Report Date
    October 28, 2021
    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
    OH, 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), BATCH: 7081348.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DID NOT HAVE THERAPEUTIC RESPONSE FOR THE RIGHT SIDE OF HIS BODY. A LEAD RECONSTRUCTION WAS PERFORMED AND THE PHYSICIAN NOTED THAT THE LEAD WAS APPROXIMATELY 7MM DORSAL TO THE TARGET. THE COMPUTED TOMOGRAPHY SCAN (CT) SCAN USED FOR THE RECONSTRUCTION WAS ACQUIRED ONE MONTH POSTOP. THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE LEAD MIGRATION. THE BURR HOLE COVER AND CLIP WERE SECURE UPON OPENING THE SCALP DURING THE PROCEDURE. THE PHYSICIAN STATED THAT HE HAD FAILED TO PUT IN A STRAIN RELIEF LOOP FOR THE LEAD. THE PHYSICIAN ALSO STATED THAT HE MUST HAVE PULLED THE LEAD DURING THE STAGE TWO PROCEDURE, WHICH CAUSED THE LEAD MIGRATION. UPON TESTING, THE PATIENT HAD GOOD CLINICAL RESPONSE. ADDITIONAL INFORMATION WAS RECEIVED THAT ONLY THE RIGHT LEAD (DB-2202-45 SERIAL NUMBER (B)(6) MIGRATED. BOTH LEADS REMAIN IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT HAVE THERAPEUTIC RESPONSE FOR THE RIGHT SIDE OF HIS BODY. A LEAD RECONSTRUCTION WAS PERFORMED AND THE PHYSICIAN NOTED THAT THE LEAD WAS APPROXIMATELY 7MM DORSAL TO THE TARGET. THE COMPUTED TOMOGRAPHY SCAN (CT) SCAN USED FOR THE RECONSTRUCTION WAS ACQUIRED ONE MONTH POSTOP. THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE LEAD MIGRATION. THE BURR HOLE COVER AND CLIP WERE SECURE UPON OPENING THE SCALP DURING THE PROCEDURE. THE PHYSICIAN STATED THAT HE HAD FAILED TO PUT IN A STRAIN RELIEF LOOP FOR THE LEAD. THE PHYSICIAN ALSO STATED THAT HE MUST HAVE PULLED THE LEAD DURING THE STAGE TWO PROCEDURE, WHICH CAUSED THE LEAD MIGRATION. UPON TESTING, THE PATIENT HAD GOOD CLINICAL RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347537 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 5172976 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention