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

Model Number	DB-1110-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, approximate event based on the day of explant.Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db220145dc0.Model: db-2201-45dc.Serial: (b)(6).Batch: 19099926.Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db220145dc0.Model: db-2201-45dc.Serial: (b)(6).Batch: 19152493.Udi: (b)(4).Product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 18878625.Udi: (b)(4).Product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 19090130.Udi: (b)(4).Product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4600-c.Batch: 18766587.Udi: (b)(4).Product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4600-c.Batch: 19078180.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a replacement surgery during which all implanted devices were removed.The reason for the explantation remains unknown.The explanted devices will not be returned for analysis, as they were discarded by the medical facility.No further information has been obtained.
Additional Manufacturer Narrative
Block b3: exact date unknown, approximate event based on gfe answer that states around february.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db220145dc0, model: db-2201-45dc, serial: (b)(6), batch: 19099926, udi: (b)(4).Product family: dbs-linear leads, upn: m365db220145dc0, model: db-2201-45dc, serial: (b)(6), batch: 19152493, udi: (b)(4).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 18878625, udi: (b)(4).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 19090130, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600-c, batch: 18766587, udi: (b)(4).Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600-c, batch: 19078180, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a replacement surgery during which all implanted devices were removed.The reason for the explantation remains unknown.The explanted devices will not be returned for analysis, as they were discarded by the medical facility.No further information has been obtained.Additional information was received stating that the there were no issues during the surgery, and the device was functioning properly.The dbs system was electively replaced to better align with the progression of the disease.

• Brand Name: VERCISE?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22779265
• Report Number: 3006630150-2025-06381
• Device Sequence Number: 8256827
• Product Code: NHL
• UDI-Device Identifier: 08714729820758
• UDI-Public: (01)08714729820758(17)170817(10)18265283
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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,Followup
• Report Date (Section B): 09/19/2025

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: 08/17/2017
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 18265283
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/19/2025
• Date Device Manufactured: 08/17/2015
• 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: 74 YR
• Patient Sex: Female