MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-2202-45

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Cognitive Changes (2551)

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event.Product family dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(4), batch: (b)(4).

Event Description

It was reported that the patient, that was enrolled in a clinical study, on the day of the implant procedure experienced a serious adverse event of left thalamocapsular hemorrhage, which was severe.The patient was thereafter hospitalized.The event was assessed to be causally related to the procedure, and not device related.The event is resolving, and the patient is recovering.The devices remain implanted and there is no further course of action.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family dbs-linear leads, upn m365db2202450, model db-2202-45, serial (b)(6), batch (b)(6).

Event Description

It was reported that the patient, that was enrolled in a clinical study, on the day of the implant procedure experienced a serious adverse event of left thalamocapsular hemorrhage, which was severe.The patient was thereafter hospitalized.The event was assessed to be causally related to the procedure, and not device related.The event is resolving, and the patient is recovering.The devices remain implanted and there is no further course of action.Additional information was received that the patient symptoms included neurological deficits and altered state of consciousness.The implant site was left ventral intermediate nucleus, and the patient was implanted with two leads.There was no neurostimulator implanted.There was a computerized tomography scan of the brain in which a left frontal trepanation hole was observed, which serves as an entry point for the deep brain stimulation sensor, which follows a frontal trans-parenchymal trajectory and whose tip is located in the ipsilateral subthalamic region.Also, material from acute bleeding was observed along its trajectory, involving the elbow and posterior arm of the internal capsule and thalamic region, spreading slightly to the ipsilateral cerebral peduncle, with no notable associated halo effect from edema, but it changes the shape of the ipsilateral lateral ventricle.Small anterior frontal gas bubbles on the left, with no appreciable impact on the underlying brain parenchyma.Additional information was received that immediately following the procedure, the patient underwent a brain computerized tomography scan which showed thalamic and corona radiata hemorrhage, circumscribed to the electrode.No operative indication was put forward.A left frontal intracranial pressure sensor was implanted.The patient was intubated, ventilated and sedated to avoid increasing the hemorrhagic component, and transferred from the operating room to the neurocritical care unit.Additional information was received that the patient showed right lower extremity hemiparesis and right upper extremity paresis of right of right nasolabial fold plus glasgow coma scale, gcs, with drop in gcs and altered state of consciousness.The patient also experienced right side hemiparesis, which was severe in severity.

Manufacturer Narrative

Additional suspect medical device components involved in the event.Product family dbs-linear leads, upn m365db2202450, model db-2202-45, serial (b)(6), batch (b)(6).

Event Description

It was reported that the patient, that was enrolled in a clinical study, on the day of the implant procedure experienced a serious adverse event of left thalamocapsular hemorrhage, which was severe.The patient was thereafter hospitalized.The event was assessed to be causally related to the procedure, and not device related.The event is resolving, and the patient is recovering.The devices remain implanted and there is no further course of action.Additional information was received that the patient symptoms included neurological deficits and altered state of consciousness.The implant site was left ventral intermediate nucleus, and the patient was implanted with two leads.There was no neurostimulator implanted.There was a computerized tomography scan of the brain in which a left frontal trepanation hole was observed, which serves as an entry point for the deep brain stimulation sensor, which follows a frontal trans-parenchymal trajectory and whose tip is located in the ipsilateral subthalamic region.Also, material from acute bleeding was observed along its trajectory, involving the elbow and posterior arm of the internal capsule and thalamic region, spreading slightly to the ipsilateral cerebral peduncle, with no notable associated halo effect from edema, but it changes the shape of the ipsilateral lateral ventricle.Small anterior frontal gas bubbles on the left, with no appreciable impact on the underlying brain parenchyma.

Manufacturer Narrative

Additional suspect medical device components involved in the event product family dbs-linear leads upn m365db2202450 model db-2202-45 serial (b)(6) batch 7095029.

Event Description

It was reported that the patient, that was enrolled in a clinical study, on the day of the implant procedure experienced a serious adverse event of left thalamocapsular hemorrhage, which was severe.The patient was thereafter hospitalized.The event was assessed to be causally related to the procedure, and not device related.The event is resolving, and the patient is recovering.The devices remain implanted and there is no further course of action.Additional information was received that the patient symptoms included neurological deficits and altered state of consciousness.The implant site was left ventral intermediate nucleus, and the patient was implanted with two leads.There was no neurostimulator implanted.There was a computerized tomography scan of the brain in which a left frontal trepanation hole was observed, which serves as an entry point for the deep brain stimulation sensor, which follows a frontal trans-parenchymal trajectory and whose tip is located in the ipsilateral subthalamic region.Also, material from acute bleeding was observed along its trajectory, involving the elbow and posterior arm of the internal capsule and thalamic region, spreading slightly to the ipsilateral cerebral peduncle, with no notable associated halo effect from edema, but it changes the shape of the ipsilateral lateral ventricle.Small anterior frontal gas bubbles on the left, with no appreciable impact on the underlying brain parenchyma.Additional information was received that immediately following the procedure, the patient underwent a brain computerized tomography scan which showed thalamic and corona radiata hemorrhage, circumscribed to the electrode.No operative indication was put forward.A left frontal intracranial pressure sensor was implanted.The patient was intubated, ventilated and sedated to avoid increasing the hemorrhagic component, and transferred from the operating room to the neurocritical care unit.

Event Description

It was reported that the patient, that was enrolled in a clinical study, on the day of the implant procedure experienced a serious adverse event of left thalamocapsular hemorrhage, which was severe.The patient was thereafter hospitalized.The event was assessed to be causally related to the procedure, and not device related.The event is resolving, and the patient is recovering.The devices remain implanted and there is no further course of action.Additional information was received that the patient symptoms included neurological deficits and altered state of consciousness.The implant site was left ventral intermediate nucleus, and the patient was implanted with two leads.There was no neurostimulator implanted.There was a computerized tomography scan of the brain in which a left frontal trepanation hole was observed, which serves as an entry point for the deep brain stimulation sensor, which follows a frontal trans-parenchymal trajectory and whose tip is located in the ipsilateral subthalamic region.Also, material from acute bleeding was observed along its trajectory, involving the elbow and posterior arm of the internal capsule and thalamic region, spreading slightly to the ipsilateral cerebral peduncle, with no notable associated halo effect from edema, but it changes the shape of the ipsilateral lateral ventricle.Small anterior frontal gas bubbles on the left, with no appreciable impact on the underlying brain parenchyma.Additional information was received that immediately following the procedure, the patient underwent a brain computerized tomography scan which showed thalamic and corona radiata hemorrhage, circumscribed to the electrode.No operative indication was put forward.A left frontal intracranial pressure sensor was implanted.The patient was intubated, ventilated and sedated to avoid increasing the hemorrhagic component, and transferred from the operating room to the neurocritical care unit.Additional information was received that the patient showed right lower extremity hemiparesis and right upper extremity paresis of right of right nasolabial fold plus glasgow coma scale, gcs, with drop in gcs and altered state of consciousness.The patient also experienced right side hemiparesis, which was severe in severity.Additional information was received that the event was recovered on (b)(6) 2023 with sequelae, and that the patient was discharged on (b)(6) 2023.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family dbs-linear leads, upn m365db2202450, model db-2202-45, serial (b)(6), batch (b)(6).

• Brand Name: VERCISE CARTESIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16008515
• MDR Text Key: 305779868
• Report Number: 3006630150-2022-07085
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7095033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 12/18/2022; 01/13/2023; 01/24/2023; 01/18/2024
• Supplement Dates FDA Received: 01/13/2023; 01/20/2023; 02/20/2023; 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male