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 or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the deep brain stimulation (dbs) database analysis performed identified a bluetooth fault code when charging the implantable pulse generator (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.The ipg remains implanted in the patient and delivering therapy.
Additional Manufacturer Narrative
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 E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50225892
• Report Number: 3006630150-2026-05831
• Device Sequence Number: 10296957
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)240329(10)537681
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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 Expiration Date: 03/29/2024
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 537681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 03/30/2022
• 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: 33 YR
• Patient Sex: Male