MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERCISE?; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-9218-15
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: nhl, pjs.
Event or Problem Description
It was reported that a deep brain stimulation (dbs) patient, implanted with a non-boston scientific lead and lead extensions, experienced a fall that resulted in high impedances readings.The patient subsequently underwent a revision procedure, during which both the lead extension and the adapter were replaced.The patient is recovering well postoperatively.The adaptor will not be returned for analysis, as it was disposed of by the medical facility.

• Brand Name: VERCISE?
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22495840
• Report Number: 3006630150-2025-05460
• Device Sequence Number: 15203774
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: (01)08714729905196(17)220119(10)7070473
• 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: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 01/19/2022
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7070473
• 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: 06/20/2025
• Initial Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 01/20/2020
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White