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

Model Number DB-2202-45

Device Problem Unintended Movement (3026)

Patient Problems Nausea (1970); Blurred Vision (2137); Visual Disturbances (2140)

Event Date 05/11/2021

Event Type  Injury  

Event Description

It was reported that during a stage i deep brain stimulator (dbs) implant procedure, the physician inserted the lead beyond the intended target; and as a result, in the patient experienced symptoms of nausea and blurred vision.The physician reinserted the lead at the intended target, and the procedure concluded without further incident.Post-operatively magnetic resonance imaging (mri) revealed the lead was well positioned, and the patient experienced relief from the aforementioned symptoms.A week later, the patient successfully completed the stage ii procedure, but reported double vision and difficulty tracking with her left eye.No further information has been obtained despite good faith efforts.

Event Description

It was reported that during a stage i deep brain stimulator (dbs) implant procedure, the physician inserted the lead beyond the intended target; and as a result, in the patient experienced symptoms of nausea and blurred vision.The physician reinserted the lead at the intended target, and the procedure concluded without further incident.Post-operatively magnetic resonance imaging (mri) revealed the lead was well positioned, and the patient experienced relief from the aforementioned symptoms.A week later, the patient successfully completed the stage ii procedure, but reported double vision and difficulty tracking with her left eye.No further information has been obtained despite good faith efforts.Additional information received stated the physician assessed the patient's double vision was caused by swelling of the cranial nerve iii and her vision would continue to improve and resolve.No further action has been scheduled.

• 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: 11924329
• MDR Text Key: 254054749
• Report Number: 3006630150-2021-02615
• 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: 06/25/2021

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: 01/15/2023
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7079427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR