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 Codes	Paresthesia (4421); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced transient shocking sensations and paresthesia radiating from the right fingertips to the right jaw.According to the patient, the initial episodes occurred on two separate occasions while sitting stationary and watching television.Following these events, the patient met with the sales representative, who performed a full impedance check.All impedance values were found to be within the normal range.Due to the patient's significant cardiac history, including a previous widow-maker heart attack, the patient was referred to a cardiologist for evaluation.The patient was seen by the cardiologist, and no obvious cardiac abnormalities were identified.The patient reported that an electrocardiogram (ekg) was performed and yielded normal results, indicating that the reported symptoms were not cardiac-related.The patient denied charging the device, undergoing any surgical or diagnostic procedures such as magnetic resonance imaging (mri), or experiencing any injury or fall at the time of the reported events.During a subsequent discussion, the patient reported one additional transient episode of a similar paresthesia-like sensation.The patient further confirmed that tremor benefit remains unchanged and that no adverse outcomes or other issues have been reported.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.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: 50145522
• Report Number: 3006630150-2026-05598
• Device Sequence Number: 15790109
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)260923(10)770752
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2026

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: 09/23/2026
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 770752
• 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: 07/16/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; 09/07/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 08/19/2026; 08/19/2026; 09/28/2026
• Date Device Manufactured: 09/23/2024
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male