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

Model Number DB-2202-45

Device Problem High impedance (1291)

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Intracranial Hemorrhage (1891)

Event Date 01/11/2023

Event Type  Death  

Event Description

It was reported that the patient underwent a revision procedure to replace the deep brain stimulation (dbs) lead due to low impedances and a short between contact one and seven.It was noted that the lead prevented the patient from getting magnetic resonance imaging (mri).The physician decided to replace the lead instead of implanting a second lead on the other side.The procedure went as expected and the patient was awake for the procedure.Following the procedure, the patient had a post-operative computerized tomography (ct) scan and a brain bleed was discovered.The patient remained in the hospital following the procedure.After a couple days, the patient seemed to be doing better.However, the patient developed other complications and passed away early morning.The explanted lead is expected to be returned for device analysis.

Event Description

It was reported that the patient underwent a revision procedure to replace the deep brain stimulation (dbs) lead due to low impedances and a short between contact one and seven.It was noted that the lead prevented the patient from getting magnetic resonance imaging (mri).The physician decided to replace the lead instead of implanting a second lead on the other side.The procedure went as expected and the patient was awake for the procedure.Following the procedure, the patient had a post-operative computerized tomography (ct) scan and a brain bleed was discovered.The patient remained in the hospital following the procedure.After a couple days, the patient seemed to be doing better.However, the patient developed other complications and passed away early morning.The explanted lead is expected to be returned for device analysis.Additional information was received that the lead revision caused bleeding in the brain and a stroke.Following the procedure, the patient had a pulmonary embolism, which led to the patients death.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: 7099225.The returned lead db-2202-45 serial number (b)(6) was analyzed and the reported observations could not be confirmed with testing of the product return.However, visual inspection revealed that the lead was cleanly cut into two pieces approximately 20.5 cm from the distal end of the lead.The clean-cut damage is a result of a typical explant procedure.No other anomalies were identified on the returned portion of the lead.A labeling review was performed on the returned lead db-2202-45 serial number (b)(6) and it did not reveal any anomalies.The instructions for use (ifu) states that injury to areas next to the implant, such as blood vessels, nerves, the chest wall, and the brain, death, and failure or malfunction of any part of the device, including but not limited to: battery leakage, battery failure, lead or extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits, and lead insulation breaches, whether or not these problems require device removal and/or replacement are known risks with the use of deep brain stimulation.Laboratory analysis of the returned device did not reveal any anomalies on the returned portion of the lead aside from the clean-cut.Technicians confirmed through technical analysis that the clean cut damage was a result of a typical procedure and it is not considered the reason for the reported event.The electrical test could not be performed due to the cut lead body.Additionally, a labeling review was conducted and this review determined that the reported hemorrhage and death are known risks with the use of deep brain stimulation.

• 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: 16279494
• MDR Text Key: 308576483
• Report Number: 3006630150-2023-00340
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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: 10/15/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7077422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• 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): Death; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male