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

Model Number	DB-1216
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Inappropriate Device Stimulation of Tissue (4928)
Date of Event	07/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a deep brain stimulation (dbs) patient experienced an intermittent vibrating sensation in the chest, with episodes lasting from approximately one to several minutes.These events occurred over a period of two consecutive days.Due to concern that the symptoms could be indicative of atrial fibrillation, the patient presented to an urgent care facility for evaluation.The dbs stimulation was temporarily deactivated, and an electrocardiogram (ekg) was performed.The ekg findings were normal, and the dbs stimulation was subsequently reactivated.No recurrence of the chest vibration sensation has been reported since that time.Following the event, the patient was doing well and stimulation therapy was unaffected.
Additional Manufacturer Narrative
D2b: additional pro code selection that applies to the indication of this device - .

• 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: 50334628
• Report Number: 3006630150-2026-06066
• Device Sequence Number: 5468940
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)260523(10)759169
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/23/2026
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 759169
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/13/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 05/23/2024
• 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
• Patient Age: 79 YR
• Patient Sex: Female