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

Model Number	DB-2203-45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Perforation (2001)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, based off bsc aware date additional suspect medical device components involved in the event: upn: m365db2203450 model: db-2203-45 serial: (b)(6).Batch: 5002075 udi: (b)(4).Product family: dbs-extension upn: m365db3216550 model: db-3216-55 serial: (b)(6).Batch: 5002208 udi: (b)(4).Product family: dbs-extension upn: m365db3216550 model: db-3216-55 serial: (b)(6).Batch: 5002211 udi: (b)(4).Product family: dbs-ipg-r-mri upn: m365db12320 model: db-1232 serial: (b)(6).Batch: 795508 udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced dehiscence at the lead/lead extension site where a lead had protruded through the skin.Therefore, the patient underwent an explant procedure of their dbs system and a culture was taken intraoperatively.Due to hospital policy, the culture results were unable to be disclosed to bsc.There were no reported patient complications postoperatively and the patient was placed on antibiotic medication.The explanted devices will not be returned as they were retained by the customer.
Additional Manufacturer Narrative
The devices were not returned for analysis as they were retained by the customer.As such, physical analysis was unable to be performed.However, it was confirmed these devices met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed that implant site complications such as pain, poor healing, redness, warmth, swelling or wound reopening as well as infection are known risks with use of dbs.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.Block b3: exact date unknown, based off bsc aware date additional suspect medical device components involved in the event: model number/catalog number: db-2203-45.Serial number: (b)(6).Batch/lot number: 5002075.Model/catalog description: argyle lead 45cm sterile kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-3216-55.Serial number: (b)(6).Batch/lot number: 5002211.Model/catalog description: argyle extension 55cm sterile kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-3216-55.Serial number: (b)(6).Batch/lot number: 5002208.Model/catalog description: argyle extension 55cm sterile kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-1232.Serial number: (b)(6).Batch/lot number: 795508.Model/catalog description: vercise genus r32 ipg kit.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced dehiscence at the lead/lead extension site where a lead had protruded through the skin.Therefore, the patient underwent an explant procedure of their dbs system and a culture was taken intraoperatively.Due to hospital policy, the culture results were unable to be disclosed to bsc.There were no reported patient complications postoperatively and the patient was placed on antibiotic medication.The explanted devices will not be returned as they were retained by the customer.

• 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: 24352005
• Report Number: 3006630150-2026-00925
• Device Sequence Number: 14661671
• Product Code: NHL
• UDI-Device Identifier: 08714729966340
• UDI-Public: (01)08714729966340(17)270121(10)5002665
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DB-2203-45
• Device Catalogue Number: DB-2203-45
• Device Lot Number: 5002665
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 01/21/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Race: White