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

Model Number DB-1216

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Shaking/Tremors (2515); Insufficient Information (4580)

Event Date 04/01/2024

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced worsening parkinsons disease, rigidity bradykinesia, and tremor due to inadequate stimulation.Reprogramming of the dbs system was unsuccessful.The patient increased dosage of levodopa to treat the worsening parkinsons symptoms.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced worsening parkinsons disease, rigidity bradykinesia, and tremor due to inadequate stimulation.Reprogramming of the dbs system was unsuccessful.The patient increased dosage of levodopa to treat the worsening parkinsons symptoms.Additional information was received that the physician opted to keep the bsc system in place at the subthalamic nucleus and to implant a non-bsc electrode in the globus pallidus internus (gpi).The patient was doing well post-operatively.

• 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: 19160687
• MDR Text Key: 340792723
• Report Number: 3006630150-2024-02523
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P150031
• 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,Followup
• Report Date: 07/08/2024

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 Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 577342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 06/28/2024
• Supplement Dates FDA Received: 07/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2023
• 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 Age: 58 YR
• Patient Sex: Female