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

Model Number	DB-1200-S
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional pro codes nhl, pjs.
Event or Problem Description
It was reported that during the scheduled deep brain stimulation (dbs) procedure, the physician encountered a failure in establishing communication between the implantable pulse generator (ipg) and the functioning remote control during device functional testing.Multiple attempts were made to reestablish communication, but all efforts were unsuccessful.The physician elected to replace the non-communicating ipg with an alternative model and as a result the procedure was completed without further complications.The patient did well postoperatively.
Event or Problem Description
It was reported that during the scheduled deep brain stimulation (dbs) procedure, the physician encountered a failure in establishing communication between the implantable pulse generator (ipg) and the functioning remote control during device functional testing.Multiple attempts were made to reestablish communication, but all efforts were unsuccessful.The physician elected to replace the non-communicating ipg with an alternative model and as a result the procedure was completed without further complications.The patient did well postoperatively.
Additional Manufacturer Narrative
Analysis of the returned vercise gevia implantable pulse generator (ipg) passed all functional tests, exhibited normal device characteristics, successfully charged within four hours, and established communication with a functioning remote control (rc) and clinician programmer (cp).A review of product labeling confirmed the device was used in accordance with the instructions for use (ifu).The ifu also notes that hardware malfunctions and the need for revision are known risks associated with deep brain stimulation (dbs) systems.Based on the available information, boston scientific concludes that the reported communication issue could not be confirmed.The ipg functioned as intended, and the probable cause is classified as no problem detected.

• 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: 22080679
• Report Number: 3006630150-2025-03607
• Device Sequence Number: 15629098
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: (01)08714729984443(17)210116(10)737090
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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): 09/09/2025

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: 01/16/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 737090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2019
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Race: White