BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 19415634 · Received May 29, 2024

    Report

    Report Number
    3006630150-2024-03450
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    September 1, 2023
    Report Date
    October 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905271
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7080434. PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 561379.

    Additional Manufacturer Narrative · 0

    THE RETURNED IPG DB-1216 SERIAL NUMBER (B)(6) REVEALED COMMUNICATION COULD NOT BE ESTABLISHED WITH A KNOWN GOOD REMOTE CONTROL OR CLINICIAN PROGRAMMER. THEREFORE, THE DATA LOGS COULD NOT BE RETRIEVED OR ANALYZED, AND NO FUNCTIONAL TESTING COULD BE PERFORMED. THE IPG WAS THEN CUT OPEN, AND INTERNAL ELECTRICAL MEASUREMENTS REVEALED EXCESSIVE SLEEP CURRENT AND LOW RESISTANCE OF A NODE WHERE HIGH RESISTANCE WAS EXPECTED, WHICH CONFIRMS THAT THE APPLICATION-SPECIFIC INTEGRATED CIRCUIT ASIC CHIP IS DAMAGED. THIS DAMAGE IS TYPICALLY CAUSED BY THE IPG EXPOSURE TO ELECTROCAUTERY. A PRODUCT LABELING REVIEW WAS CONDUCTED. THIS REVIEW DETERMINED THAT THE PROCEDURE OF ELECTROCAUTERY MAY TURN STIMULATION OFF OR MAY CAUSE PERMANENT DAMAGE TO THE STIMULATOR. IF THIS TYPE OF PROCEDURE IS REQUIRED BY MEDICAL NECESSITY, THE PROCEDURE SHOULD BE PERFORMED AS FAR FROM THE IMPLANTED COMPONENTS AS POSSIBLE. THE RETURNED LEAD DB-2202-30 SERIAL NUMBER (B)(6) WAS ANALYZED AND VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT INTO TWO PIECES APPROXIMATELY 11 CM FROM THE PROXIMAL END OF THE LEAD AND THE DISTAL PORTION OF THE LEAD WAS NOT RETURNED. THE CLEAN-CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. ELECTRICAL TEST COULD NOT BE PERFORMED DUE THE CUT LEAD BODY. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEAD. A LABELING REVIEW WAS CONDUCTED. THIS REVIEW DETERMINED THAT LOSS OF ADEQUATE STIMULATION, GAIT DIFFICULTY, TROUBLE WALKING, FALLS AND WEAKNESS, MUSCLE SPASMS, SHAKING, RESTLESSNESS, OR PROBLEMS WITH MOVEMENT ARE A KNOWN RISK WITH THE USE OF DEEP BRAIN STIMULATION. THE LEAD DB-2202-30 SERIAL NUMBER 7080471 WAS NOT RETURNED FOR ANALYSIS. THEREFORE, ANALYSIS COULD NOT BE COMPLETED IN OUR LABORATORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED LEAD MIGRATION OF THE LEFT BRAIN LEAD WHEREIN IT WAS NO LONGER AT TARGET POSITION. THE PATIENT WAS EXPERIENCING DIFFICULTY WALKING, RUNNING AND A PROGRESSION OF DYSTONIA SYMPTOMS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEFT-BRAIN LEAD WAS REPLACED. THE PHYSICIAN DECIDED TO REPLACE THE RIGHT BRAIN LEAD AS WELL TO ACHIEVE BETTER THERAPEUTIC RESULTS. DURING THE PROCEDURE MONOPOLAR ELECTROCAUTERY WAS PERFORMED. COMMUNICATION BETWEEN THE REMOTE CONTROL AND THE IMPLANTABLE PULSE GENERATOR (IPG) FAILED. AFTER MULTIPLE ATTEMPTS TO COMMUNICATE WITH THE IPG, THE SURGEON DECIDED TO REPLACE THE IPG DUE TO SUSPECTED DAMAGE FROM ELECTROCAUTERY. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED LEAD MIGRATION OF THE LEFT BRAIN LEAD WHEREIN IT WAS NO LONGER AT TARGET POSITION. THE PATIENT WAS EXPERIENCING DIFFICULTY WALKING, RUNNING AND A PROGRESSION OF DYSTONIA SYMPTOMS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEFT-BRAIN LEAD WAS REPLACED. THE PHYSICIAN DECIDED TO REPLACE THE RIGHT BRAIN LEAD AS WELL TO ACHIEVE BETTER THERAPEUTIC RESULTS. DURING THE PROCEDURE MONOPOLAR ELECTROCAUTERY WAS PERFORMED. COMMUNICATION BETWEEN THE REMOTE CONTROL AND THE IMPLANTABLE PULSE GENERATOR (IPG) FAILED. AFTER MULTIPLE ATTEMPTS TO COMMUNICATE WITH THE IPG, THE SURGEON DECIDED TO REPLACE THE IPG DUE TO SUSPECTED DAMAGE FROM ELECTROCAUTERY. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838268 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-30 7080471 08714729905271

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Required Intervention