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

Model Number	DB-3216-55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Pain (1994); Impaired Healing (2378); Localized Skin Lesion (4542)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information has not been provided by the facility.Block b3: date of event unknown, approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5002888, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient presented with dehiscence at the lead extension incision site behind the ear.It was noted that the incision was not healing properly.The patient underwent intervention wherein the incision site was cleaned with iodine and treated with antibiotics before completing the procedure.The lead extensions remain implanted.The patient was placed on a regimen of steroids and antibiotics and has since developed a scab.Ongoing care is being provided by the treating physician.
Additional Manufacturer Narrative
Block b5 describe event or problem updated.Block b3: approximated based on the date the manufacturer became aware of the event.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information has not been provided by the facility.Additional suspect medical device components involved in the event: product family: dbs-extension.Upn: m365db3216550.Model: db-3216-55.Serial: (b)(6).Batch: 5002888.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient presented with dehiscence at the lead extension incision site behind the ear.It was noted that the incision was not healing properly.The patient underwent intervention wherein the incision site was cleaned with iodine and treated with antibiotics before completing the procedure.The lead extensions remain implanted.It is unclear whether cultures were obtained.The patient was placed on a regimen of steroids and antibiotics and has since developed a scab.Ongoing care is being provided by the treating physician.Additional information received indicated that the patient experienced pain and purulent discharge at the incision site.The patient is doing well and wound has since then closed.

• 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; 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: 23824067
• Report Number: 3006630150-2025-11491
• Device Sequence Number: 21153651
• Product Code: NHL
• UDI-Device Identifier: 08714729966395
• UDI-Public: (01)08714729966395(17)270727(10)5002885
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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 Model Number: DB-3216-55
• Device Catalogue Number: DB-3216-55
• Device Lot Number: 5002885
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 12/23/2025
• Date Device Manufactured: 07/27/2025
• 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: 70 YR
• Patient Sex: Male
• Patient Race: White