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

Model Number	DB-1110-C
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Movement Disorder (4412); Insufficient Information (4580)
Date of Event	07/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient was experiencing difficulty establishing communication between the remote control and the implantable pulse generator (ipg), which led to symptoms of slowed movement.Throughout the day, there was no improvement, and the patient was later admitted to the emergency room due to a choking incident.It was discovered that the stimulation had inadvertently been turned off; therefore, the stimulation was reactivated after which the patient immediately became more responsive.The patient is expected to make a full recovery.The device will not return for analysis as it remains implanted.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient was experiencing difficulty establishing communication between the remote control and the implantable pulse generator (ipg), which led to symptoms of slowed movement and weakness.Throughout the day, there was no improvement, and the patient was later admitted to the emergency room due to a choking incident.It was discovered that the stimulation had inadvertently been turned off; therefore, the stimulation was reactivated after which the patient immediately became more responsive.The patient is expected to make a full recovery.The device will not return for analysis as it remains implanted.Additional information was received indicating that, based on the physician's assessment, the choking episode is considered part of the patients disease progression.
Additional Manufacturer Narrative
Correction to the initial mdr in blocks b5 and h6.

• Brand Name: VERCISE?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22638313
• Report Number: 3006630150-2025-05912
• Device Sequence Number: 21216912
• Product Code: NHL
• UDI-Device Identifier: 08714729820758
• UDI-Public: (01)08714729820758(17)170204(10)17651144
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/04/2017
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 17651144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 02/05/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male