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

Model Number DB-1216

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

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Paralysis (1997); Dyskinesia (2363)

Event Date 03/06/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced right hand paralysis.The neurologist suspected a cerebral vascular accident (cva) however a computed tomography (ct) scan, and magnetic resonance imaging (mri) ruled out a cva.The patients symptoms deteriorated after leaving the neurologist office.The patient experienced convulsions.The patient was prescribed diazepam and propranolol which helped with the convulsing symptoms, the device was then turned off and the convulsions resolved.The patient was able to complete both mri and ct scans.Device impedance measurements were normal, however, the physician reprogramed the device therapy.The mri and ct scans showed no pathology explaining the patients hand paralysis/weakness.The physician assessed that the reprogramming earlier in the day could have been the cause of the dyskinesia/convulsions.The neurologist observed hand paralysis, however, a couple days later the patient was able to move both hands and fingers.The patient continues to be monitored for psychological evaluation.

• Brand Name: VERCISE GENUS
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16676030
• MDR Text Key: 312632160
• Report Number: 3006630150-2023-01772
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2023

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: 03/02/2024
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 535810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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): Required Intervention
• Patient Sex: Female