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

Model Number	DB-1232
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patients deep brain stimulation (dbs) implantable pulse generator (ipg) necessitated frequent charging cycles.It was noted dbs system had been reprogrammed prior to the onset of these issues, and impedance measurements were within range.Data analysis indicated voltage fluctuations during and after charging, beginning approximately three months ago.The battery voltage spiked to full during charging but dropped significantly post-charge, exhibiting rapid battery depletion following a full charge.The root cause of this behavior could not be determined with the data analysis.A labeling review confirmed that no manufacturing deviations were noted that could have contributed to the event reported.The ipg was approved for warranty replacement, and the patient underwent a procedure to replace it with an identical model.Postoperatively, the patient recovered well and no longer experiences charging issues.
Additional Manufacturer Narrative
Section d2b additional pro codes, nhl, pjs.
Event or Problem Description
It was reported that the patients deep brain stimulation (dbs) implantable pulse generator (ipg) necessitated frequent charging cycles.It was noted dbs system had been reprogrammed prior to the onset of these issues, and impedance measurements were within range.Data analysis indicated voltage fluctuations during and after charging, beginning approximately three months ago.The battery voltage spiked to full during charging but dropped significantly post-charge, exhibiting rapid battery depletion following a full charge.The root cause of this behavior could not be determined with the data analysis.A labeling review confirmed that no manufacturing deviations were noted that could have contributed to the event reported.The ipg was approved for warranty replacement, and the patient underwent a procedure to replace it with an identical model.Postoperatively, the patient recovered well and no longer experiences charging issues.
Additional Manufacturer Narrative
Based on all available information, boston scientific determined that the frequent ipg charging was caused by a defective internal battery cell exhibiting elevated and fluctuating resistance, which prevented the device from maintaining a full charge.Analysis of the returned vercise genus confirmed that the ipg could be fully charged in a single cycle; however, data logs showed multiple false double beeps, voltage spikes, and rapid depletion from 4.0 v to 3.4 to 3.6 v.Internal electrical testing further confirmed elevated and unstable battery cell resistance.A review of the devices manufacturing records found no anomalies or deviations related to this issue.Additionally, labeling also notes that battery failure, leakage, or other hardware malfunctions may occur and may require device removal or replacement, as described in the instructions for use (ifu).Based on all the available information, engineering analysis determined that the frequent charging was attributable to a component failure resulting from fluctuating and elevated resistance within the battery cell.Section d2b additional pro codes, nhl, pjs.

• Brand Name: VERCISE GENUS?
• 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: 23843971
• Report Number: 3006630150-2025-11542
• Device Sequence Number: 9527270
• Product Code: MHY
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)270119(10)780261
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 780261
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2025
• 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
• Patient Age: 73 YR
• Patient Sex: Male