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 Swelling (2091); Complaint, Ill-Defined (2331); Confusion/ Disorientation (2553)

Event Date 11/05/2020

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); lot: 7076168.

Event Description

It was reported that prior to turning stimulation on and being discharged the patient experienced cognitive issues as well as brain swelling which resulted in alter consciousness.An mri was taken but results are unavailable.The patients system was programmed and stimulation has since been turned.The patients status is unknown as the issue is ongoing.

Event Description

It was reported that prior to turning stimulation on and being discharged the patient experienced cognitive issues as well as brain swelling which resulted in alter consciousness.An mri was taken but results are unavailable.The patients system was programmed and stimulation has since been turned.The patients status is unknown as the issue is ongoing.Additional information was received that the patient is doing extremely well post-operatively.

• 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: 10906414
• MDR Text Key: 218496322
• Report Number: 3006630150-2020-05827
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/29/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7075220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR