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

Model Number DB-2202-30

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

Patient Problems Edema (1820); No Code Available (3191)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient enrolled in the (b)(4) clinical study (b)(4) experienced edema around the lead with clinical insufficient effect which was moderate in severity.The patient was showing signs of bradykinesia on the right side.There was no sign of infection.Patient was treated with medication and had a cmri.Patient was hospitalized and then discharged a few days later.The patient was noted to have fully recovered.

Event Description

It was reported that the patient enrolled in the vercise deep brain stimulation dbs registry clinical study a4010 experienced edema around the lead with clinical insufficient effect which was moderate in severity.The patient was showing signs of bradykinesia on the right side.There was no sign of infection.Patient was treated with medication and had a cmri.Patient was hospitalized and then discharged a few days later.The patient was noted to have fully recovered.Boston scientific subsequently received information indicating the patient presented to the emergency room on (b)(6) 2020 due to a worsening in mobility on the left side of her body.The patient was instructed to increase levodopa medication and as a result her movement improved.On (b)(6) 2020 the patient presented with worsening movement, especially on her right side.In-depth testing of the stimulator revealed neither side effects under amplitude increases, nor an exacerbation of the parkinsons symptoms after turning off the device.The device remained off and the levodopa dose was increased.During admission a cranial x-ray and cct were performed and showed unchanged location of the dbs deep brain stimulation leads.Patient was discharged on (b)(6) 2020.The patient was re-admitted to the hospital on (b)(6) 2020 due to worsening movement on the right side of her body.A cct was performed and parenchyma abnormality could be seen at the base of the brain on the left.A repeat cmri with contrast was performed and the lesion did not appear to be impaired by bounds and further cerebrospinal-fluid diagnostics showed increased cell count or other evidence of an inflammatory etiology.The patients medication was returned to its original dosage and was discharged from the hospital on (b)(6) 2020.The patient was noted to have fully recovered (b)(6) 2020.This adverse event was possibly related to stimulation and device hardware, not related to the procedure.

• 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: 10805396
• MDR Text Key: 215258653
• Report Number: 3006630150-2020-05414
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• 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
• Report Date: 01/21/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/23/2020
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 5025077
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention