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

Model Number	DB-2202-45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Rash (2033)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed a scalp rash in the area of the deep brain stimulation (dbs) implant.The patient did not seek medical treatment for several weeks and reportedly concealed the rash with a wig.Upon evaluation by the neurosurgery team, the patient was referred to a dermatologist for further assessment.Dermatologic treatment was initiated and the rash resolved; however, resolution of the rash revealed complete erosion of the overlying skin with full exposure of the burr hole cover.The patient was also reported to be on long-term steroid therapy, which was considered a potential contributing factor due to compromised skin thickness and elasticity.As part of the intervention, the lead and burr hole cover associated with the exposed hardware were explanted.The wound was cleaned, and a plastic surgery team performed closure of the surgical site.Postoperatively, the patient's status was not reported.The explanted devices will not be returned for analysis, as they were disposed of.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d.2b; additional applicable product codes: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-4600-c.Serial number: na.Batch/lot number: 35357578.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) #: (b)(4).

• Brand Name: Vercise? Cartesia?
• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50136742
• Report Number: 3006630150-2026-05562
• Device Sequence Number: 17538908
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)270206(10)7133996
• 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
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2026

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 Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7133996
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: Not provided; 09/18/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/03/2026; 10/02/2026
• Date Device Manufactured: 02/05/2025
• 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: 85 YR
• Patient Sex: Female