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

Model Number	DB-1200-S
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Charging Problem (2892); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced communication difficulties with the implantable pulse generator (ipg) and could not turn therapy back on after a medical procedure as a result, the patient was in pain and discomfort therefore was admitted.It was noted that dbs was functioning properly and therapy was manually turned off in order to complete a cardioversion procedure.Attempts to recharge the ipg and reestablish communication using a functional clinician programmer (cp) and remote-control (rc) were unsuccessful.The patient underwent a procedure wherein the ipg was replaced with a different model before completing the procedure.Analysis of the ipg was not performed as it was discarded by the facility.The patient was successfully programmed resulting in return of their therapy.Patient did well post-operatively.It was reported that the deep brain stimulation (dbs) patient experienced pain and discomfort following a non-dbs medical procedure.The patient could not turn therapy back on and experienced communication difficulties with the implantable pulse generator (ipg) resulting with prolonged hospitalization.It was noted that dbs was functioning properly and therapy was manually turned off prior to cardioversion procedure.Attempts to recharge the ipg and reestablish communication using a functional clinician programmer (cp) and remote-control (rc) were unsuccessful.The patient underwent a procedure wherein the ipg was replaced with a different model before completing the procedure.Analysis of the ipg was not performed as it was discarded by the facility.The patient was successfully programmed resulting in return of their therapy.Patient did well post-operatively.
Additional Manufacturer Narrative
Block d2b additional pro codes, nhl, pjs.
Additional Manufacturer Narrative
Based on the available information (in the absence of the product return) boston scientific has determined that the loss of stimulation and communication difficulties are a known inherent risk with use of the implantable pulse generator (ipg), as documented in the instructions for use (ifu).A review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.The device was not returned as it was discarded by the facility; as such, physical analysis was not conducted in our laboratory.A product labeling review identified that the devices were used per the ifu product label.Additionally, failure of malfunction of any device, loss of stimulation resulting in pain or discomfort are noted within the ifu as a potential risk associated with the use of the device.The implantable pulse generator ipg was discarded and not returned, as such, physical analysis was not conducted in our laboratory.However, the labeling review was conducted.This review determined that loss of stimulation and communication difficulties is a known inherent risk of implanting a pulse generator as part of a system to deliver deep brain stimulation (dbs).Block d2b additional pro codes, nhl, pjs.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced communication difficulties with the implantable pulse generator (ipg) and could not turn therapy back on after a medical procedure as a result, the patient was in pain and discomfort therefore was admitted.It was noted that dbs was functioning properly and therapy was manually turned off in order to complete a cardioversion procedure.Attempts to recharge the ipg and reestablish communication using a functional clinician programmer (cp) and remote-control (rc) were unsuccessful.The patient underwent a procedure wherein the ipg was replaced with a different model before completing the procedure.Analysis of the ipg was not performed as it was discarded by the facility.The patient was successfully programmed resulting in return of their therapy.Patient did well post-operatively.It was reported that the deep brain stimulation (dbs) patient experienced pain and discomfort following a non-dbs medical procedure.The patient could not turn therapy back on and experienced communication difficulties with the implantable pulse generator (ipg) resulting with prolonged hospitalization.It was noted that dbs was functioning properly and therapy was manually turned off prior to cardioversion procedure.Attempts to recharge the ipg and reestablish communication using a functional clinician programmer (cp) and remote-control (rc) were unsuccessful.The patient underwent a procedure wherein the ipg was replaced with a different model before completing the procedure.Analysis of the ipg was not performed as it was discarded by the facility.The patient was successfully programmed resulting in return of their therapy.Patient did well post-operatively.

• Brand Name: VERCISE GEVIA?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 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: 24415312
• Report Number: 3006630150-2026-01054
• Device Sequence Number: 5939257
• Product Code: MHY
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)210820(10)739639
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• 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): 04/03/2026

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: 08/20/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 739639
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 08/21/2019
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White