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

Model Number	DB-1216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Speech Disorder (4415); Facial Paralysis (4585)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient reported experiencing intermittent episodes characterized by an inability to initiate movement, accompanied by loss of balance and subsequent falls.During follow-up communication, the patient stated that, following initial device programming, the device had been routinely powered off at night and reactivated in the morning, based on a misunderstanding of the intended usage instructions.The patient was subsequently advised to leave the device activated continuously.The patient further reported multiple episodes of feeling unwell or experiencing an undefined sensation of being "off" immediately preceding a loss of balance.These events reportedly resulted in falls and were followed by significant difficulty recovering, including challenges with independently regaining an upright position.According to the physician, this event is not believed to be related to the device.The reported difficulty with movement was considered consistent with a severe parkinson's disease off state.Subsequently, the patient presented to the emergency room (er) with stroke-like symptoms after experiencing a fall that resulted in a tailbone fracture.The patient also reported a period of lost time that could not be accounted for, and slight facial asymmetry on the right side was observed.A stroke was not confirmed, and bell's palsy was suspected as the diagnosis.Following this event, the patient was admitted to a rehabilitation facility.The patient is currently reported to be stable.
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 ; EI
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50182562
• Report Number: 3006630150-2026-05682
• Device Sequence Number: 18210285
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)280223(10)820968
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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 Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 820968
• 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: 07/18/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 02/22/2026
• 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: Other; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female