BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERCISE PC

    MDR report key: 13233452 · Received January 11, 2022

    Report

    Report Number
    3006630150-2021-07572
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 20, 2021
    Report Date
    June 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). LOT: 7071682. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL :NM-3138-55. SERIAL : (B)(6). LOT: 7080684. THE LEAD AND LEAD EXTENSION REMAIN IMPLANTED IN THE PATIENT. THE IPG WAS A RETURNED AND THE LABORATORY ANALYSIS OF THE IPG DID NOT REVEAL ANY ANOMALIES. HOWEVER, A REVIEW OF THE DATA FOUND THAT THE IPG WAS IN SERVICE FOR ABOUT 13 MONTHS WITH AN ENERGY USE INDEX EUI RANGE OF 11.6, AND THE EXPECTED RANGE WOULD BE ABOUT 26 MONTHS PER THE DIRECTION FOR USE. THE PATIENTS DATA ALSO SHOWS A SUDDEN BATTERY DROP AT THE TIME OF THE IMPLANT PROCEDURE, FROM 3.073 VOLTS TO 2.884 VOLTS. THE INCIDENT SHORTENED THE DEVICES LONGEVITY SIGNIFICANTLY. THE ROOT CAUSE HAS NOT BEEN DETERMINED, BUT THE PROXIMAL CAUSE HAS BEEN. THE PROXIMAL CAUSE OF THE REDUCED LONGEVITY IS A HIGH VH VOLTAGE. VH, HIGH VOLTAGE IS THE VOLTAGE USED TO DRIVE THE STIMULATION AND MAINTAIN COMPLIANCE VOLTAGE AT THE ELECTRODES. THE ROOT CAUSE FOR THE HIGH VH STATE HAS NOT BEEN IDENTIFIED. HOWEVER, THERE ARE TWO POSSIBLE HYPOTHESES. EITHER THE COMPLIANCE VOLTAGE ALGORITHM CVA HAS A, AT THIS TIME UNKNOWN, FAILURE MODE THAT CAUSES VH TO BE DRIVEN HIGH FOR THE REQUIRED IMPEDANCES LOAD, OR THE IMPEDANCES LOAD WAS UNEXPECTEDLY HIGH AND THE CVA CORRECTLY INCREASED THE VH DRIVE VOLTAGE, TO ENABLE THE STIMULATION. A POSSIBLE CAUSE FOR HIGH IMPEDANCES COULD BE FROM A LEAD OR LEAD CONTACT. A CVA FAILURE MODE IS POSSIBLE, HOWEVER, BOTH POTENTIAL ROOT CAUSES ARE CONSISTENT WITH THE AVAILABLE DATA. AT THIS TIME THE ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THAT BIPOLAR ELECTROCAUTERY WAS USED DURING THE IMPLANT PROCEDURE, HOWEVER, IT IS UNKNOWN IF THE IPG WAS DIRECTLY EXPOSED. ADDITIONALLY, A PRODUCT LABELING REVIEW WAS PERFORMED FOR THE IPG AND IT DID NOT REVEAL ANY ANOMALIES. THE INSTRUCTIONS FOR USE IFU STATES; THE FOLLOWING MEDICAL THERAPIES OR PROCEDURES MAY TURN SIMULATION OFF, CAUSE PERMANENT DAMAGE TO THE STIMULATOR, OR MAY CAUSE INJURY TO THE PATIENT. THESE INCLUDE ELECTROCAUTERY, EXTERNAL DEFIBRILLATION, LITHOTRIPSY, RADIATION THERAPY, TRANSCRANIAL STIMULATION, MRI AND DIATHERMY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TREMORS IN HIS HAND RETURN DIRECTLY FOLLOWING AN AIRLINE FLIGHT. IT WAS FOUND THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR IPG DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR ERI MESSAGE AND THE BATTERY WAS DEPLETED. THE PATIENT UNDERWENT A PROCEDURE WHERE THE IPG WAS REPLACED. THE PATIENT WAS RECEIVING A GOOD RESPONSE WITH STIMULATION POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TREMORS IN HIS HAND RETURN DIRECTLY FOLLOWING AN AIRLINE FLIGHT. IT WAS FOUND THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR ERI MESSAGE AND THE BATTERY WAS DEPLETED. THE PATIENT UNDERWENT A PROCEDURE WHERE THE IPG WAS REPLACED. THE PATIENT WAS RECEIVING A GOOD RESPONSE WITH STIMULATION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737028 VERCISE PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1140 633009

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention