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

Model Number	DB-2201-45DC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Swelling/ Edema (4577)
Date of Event	02/16/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-2201-45dc, serial number: (b)(6), batch/lot number: 21126049, model/catalog description: lead kit 45cm, unique identifier (udi) #: (b)(4).Model number/catalog number: db-4600-c, batch/lot number: 21391749, model/catalog description: suretek burr hole cover kit, unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient underwent placement of a deep brain stimulation (dbs) lead.Approximately 36 hours following the procedure, the patient experienced clinical deterioration.Imaging via ct scan revealed a large venous infarct with associated hemorrhage and cerebral edema.As a result of these findings, the patient underwent an emergent right hemicraniectomy for decompression.The patient tolerated the procedure well.Retrospective information obtained from the treating institution indicated that the patient remained hospitalized following the procedure and was later reported deceased on (b)(6) 2018, approximately one month after the implant.Additional details regarding the events leading to death were not available.
Event or Problem Description
It was reported that the patient underwent placement of a deep brain stimulation (dbs) lead.Approximately 36 hours following the procedure, the patient experienced clinical deterioration.Imaging via ct scan revealed a large venous infarct with associated hemorrhage and cerebral edema.As a result of these findings, the patient underwent an emergent right hemicraniectomy for decompression.The patient tolerated the procedure well.Retrospective information obtained from the treating institution indicated that the patient remained hospitalized following the procedure and was later reported deceased on (b)(6) 2018, approximately one month after the implant.Additional details regarding the events leading to death were not available.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-2201-45dc.Serial number: (b)(6).Batch/lot number: 21126049.Model/catalog description: lead kit 45cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: db-4600-c.Serial number: batch/lot number: 21391749.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) #: (b)(4).The device was not returned to boston scientific for analysis and the complaint as reported was not able to be confirmed.A review of the device history record (dhr) was conducted.The records indicate that the device 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.There is no evidence that the device was used in an inconsistent manner with the labelled indications/instructions for use.Based upon medical review of the limited information available there is no evidence to suggest a deficiency associated with a bsc device.Operative documentation indicated that the patient experienced a venous infarction and intracerebral hemorrhage with swelling following placement of a dbs lead, requiring a hemicraniectomy.Subsequent records indicated that at least one lead was explanted during a follow-up procedure.The patient later died approximately one month after the implant procedure, with hemorrhage reported as the official cause of death.Intracerebral hemorrhage is a known risk associated with dbs implantation procedures.Based on the available information, the reported hemorrhage and subsequent death are most consistent with a complication of the implant procedure rather than a device performance issue.Therefore, in the absence of device return and analysis, the reported event is considered to be procedure related.

• Brand Name: NA
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25786370
• Report Number: 3006630150-2026-04835
• Device Sequence Number: 13433732
• Product Code: MHY
• UDI-Device Identifier: 08714729836544
• UDI-Public: (01)08714729836544(17)190915(10)21126049
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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 Expiration Date: 09/15/2019
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 21126049
• 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: 06/11/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/19/2026
• Date Device Manufactured: 09/15/2017
• 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: 73 YR
• Patient Sex: Male