MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise Genus?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-1216
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Inappropriate Device Stimulation of Tissue (4928)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a deep brain stimulation (dbs) patient experienced a sensation described as a sudden rush of weirdness while charging the implantable pulse generator (ipg).The patient did not report any pain associated with the event.The patient stated that a similar sensation had been experienced previously when the physician changed the therapy settings from one stimulation program to another.The database analysis performed identified a bluetooth fault code when charging the ipg.Noise from the charging field of the charger interferes with the bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation.No other anomalies were identified during the analysis, and the device charge log was found to be normal.The ipg remains implanted and continues to deliver therapy as intended.It was further reported that a firmware update was performed on the ipg, resolving the bluetooth fault code associated with charging.Following the update, the patient was able to successfully charge the ipg without interruption and was reported to be doing well.
Additional Manufacturer Narrative
A field safety notice (fsn; z-1890-2024) was delivered to physicians in april 2024 communicating the potential for the vercise genus deep brain stimulation (dbs) implantable pulse generator (ipg) stimulation therapy to be transiently suspended during charging due to a device reset.The device reset behavior occurs in response to the detection of potential noise/interference during ipg charging.When the system resets, the patient's programmed stimulation is suspended for approximately 10-15 seconds and then the device returns to normal operation once the reset is complete, including the delivery of stimulation therapy.In december 2023, a firmware update was implemented that will prevent this device reset behavior from occurring during ipg charging.D2b: additional pro code selection that applies to the indication of this device.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: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50216488
• Report Number: 3006630150-2026-05791
• Device Sequence Number: 12292878
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)250615(10)576466
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2026

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: 06/15/2025
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 576466
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: Not provided; 09/13/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/04/2026; 10/01/2026
• Date Device Manufactured: 06/16/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1890-2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male