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 Code	Hematoma (1884)
Date of Event	05/12/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: db-2203-45 serial number: (b)(6) batch/lot number: 5010146 model/catalog description: argyle lead 45cm sterile kit unique identifier (udi) #: (b)(4).Model number/catalog number: unk serial number: unk batch/lot number: unk model/catalog description: unk unique identifier (udi) #: unk.Model number/catalog number: db-4600-c serial number: n/a batch/lot number: 38757902 model/catalog description: suretek burr hole cover kit unique identifier (udi) #: (b)(4).Model number/catalog number: db-4600-c serial number: n/a batch/lot number: 38359013 model/catalog description: suretek burr hole cover kit unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient proceeded with the implant procedure of the deep brain stimulation (dbs) system.Upon completion of the intervention, the patient developed a subdural hematoma, which subsequently led to the patient's death.According to the physician's assessment, the procedure was determined to have contributed to the patient's complication.
Event or Problem Description
It was reported that the patient proceeded with the implant procedure of the deep brain stimulation (dbs) system.Upon completion of the intervention, the patient developed a subdural hematoma, which subsequently led to the patient's death.According to the physician's assessment, the procedure was determined to have contributed to the patient's complication.
Additional Manufacturer Narrative
The devices were not returned to boston scientific for analysis and the complaint as reported was not able to be confirmed.For cases where product identification information was available a review of the device history record (dhr) was conducted.The records indicate that the devices met all applicable acceptance criteria and release requirements prior to distribution.No manufacturing related nonconformances or deviations were identified during the review that could be associated with the reported event.For the implantable pulse generator (ipg) boston scientific was unable to obtain sufficient product identification information to determine the specific device or associated lot involved in the complaint.Therefore, a dhr review could not be conducted since lot number was not provided and a ship history review could not be performed to identify most probable lots.A risk review was completed and confirmed that the event of hematoma and death was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The investigation was limited to the information and documentation available at the time of review.Evaluation of the complaint record did not identify objective evidence to confirm the reported issue.There is no evidence that the devices were used in an inconsistent manner with the labelled indications/instructions for use.The reported allegations of intracerebral hematoma, and death were not devices related; rather, procedure related.The investigation determined that the reported hematoma and subsequent patient outcome occurred following dbs lead implantation.No evidence was identified to suggest that devices performance contributed to the reported event.Therefore, the investigation is assigned the conclusion code of adverse event related to procedure.Additional suspect medical device components involved in the event: model number/catalog number: db-2203-45.Serial number: (b)(6).Batch/lot number: 5010146.Model/catalog description: argyle lead 45cm sterile kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: unk.Serial number: unk.Batch/lot number: unk.Model/catalog description: unk.Unique identifier (udi) #: unk.Model number/catalog number: db-4600-c.Serial number: n/a.Batch/lot number: 38757902.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-4600-c.Serial number: n/a.Batch/lot number: 38359013.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) #: ((b)(4).

• 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; PR 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 25513172
• Report Number: 3006630150-2026-04128
• Device Sequence Number: 16108997
• Product Code: NHL
• UDI-Device Identifier: 08714729966340
• UDI-Public: (01)08714729966340(17)280204(10)5008532
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/14/2026

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: 5008532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 02/04/2026
• 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: Death
• Patient Age: 79 YR
• Patient Sex: Female