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 Stroke/CVA (1770); Hemorrhage, Cerebral (1889); Neurological Deficit/Dysfunction (1982); Paralysis (1997); No Code Available (3191)

Event Date 10/05/2020

Event Type  Injury  

Event Description

It was reported that the clinical study patient, a4012 vercise dbs dystonia registry, experienced severe left side intracranial hemorrhage.The patient was hospitalized and given medication.The event is assessed as casually related to the procedure and not related to the device.

Event Description

It was reported that the clinical study patient, (b)(6) vercise dbs dystonia registry, experienced severe left side intracranial hemorrhage.The patient was hospitalized and given medication.The event is assessed as casually related to the procedure and not related to the device.Additional information was received that the patient was asymptomatic after the left lead was implanted in the internal globus pallidus.In an attempt to implant the right lead, the patient presented with global aphasia and slight hemiparesis.The right lead surgery was discontinued.A computed tomography (ct) scan was performed and showed left temporal intracranial hemorrhage.The patient is currently in rehabilitation with extensive physio and ergotherapy, speech therapy and neuropsychological therapy with significant improvement.

Manufacturer Narrative

H6 patient code 3191: no code available was used as there is no equivalent fda code for additional medical intervention.

Event Description

It was reported that the clinical study patient, a4012 vercise dbs dystonia registry, experienced severe left side intracranial hemorrhage.The patient was hospitalized and given medication.The event is assessed as casually related to the procedure and not related to the device.Additional information was received that the patient was asymptomatic after the left lead was implanted in the internal globus pallidus.In an attempt to implant the right lead, the patient presented with global aphasia and slight hemiparesis.The right lead surgery was discontinued.A computed tomography (ct) scan was performed and showed left temporal intracranial hemorrhage.The patient is currently in rehabilitation with extensive physio and ergotherpay, speech therapy and neuropsychological therapy with significant improvement.Additional information was received that the patient was hospitalized and given medication following the reported ct scan.

• 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
• MDR Report Key: 10758986
• MDR Text Key: 213845131
• Report Number: 3006630150-2020-05252
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2020

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 Expiration Date: 08/11/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7075548
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 10/28/2020; 11/18/2020
• Supplement Dates FDA Received: 11/16/2020; 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention