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

Model Number	DB-1216
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Intermittent Energy Output (4025)
Health Effect - Clinical Codes	Pain (1994); Anxiety (2328); Discomfort (2330); Shaking/Tremors (2515); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction

• 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: 50177270
• Report Number: 3006630150-2026-05663
• Device Sequence Number: 15922945
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)250118(10)560838
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 01/18/2025
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 560838
• 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: 07/27/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 01/19/2023
• 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
• Patient Sex: Unknown