MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 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	Bacterial Infection (1735); Fluid Discharge (2686)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure involving complete removal of the dbs system due to infection.The patient exhibited fluid discharge at the extension site.The patient remains in recovery, and antibiotic therapy was initiated to manage the infection.The hospital has retained the explanted devices, and they will not be returned for analysis.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri upn: m365db12320, model: db-1232, serial: (b)(6), batch: (b)(6), udi: (b)(4).Product family: upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: (b)(6), udi: (b)(4).Product family: upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: (b)(6), udi: (b)(4).
Additional Manufacturer Narrative
Correction to blocks: b2, h6.Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri, upn: m365db12320, model: db-1232, serial: (b)(6), batch: 553835, udi: (b)(4).Product family: upn: m365db2203450, model: db-2203-45, serial: (b)(6), batch: 5002318, udi: (b)(4).Product family: upn: m365db3216550, model: db-3216-55, serial: (b)(6), batch: 5001458, udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure involving complete removal of the dbs system due to infection.The patient exhibited fluid discharge at the extension site.The patient remains in recovery, and antibiotic therapy was initiated to manage the infection.The hospital has retained the explanted devices, and they will not be returned for analysis.
Additional Manufacturer Narrative
Correction to blocks: b2, h6.Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri upn: m365db12320 model: db-1232 serial: (b)(6).Batch: 553835 udi: (b)(4).Product family: upn: m365db2203450 model: db-2203-45 serial: (b)(6).Batch: 5002318 udi: (b)(4).Product family: upn: m365db3216550 model: db-3216-55 serial: (b)(6).Batch: 5001458 udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure involving complete removal of the dbs system due to infection.The patient exhibited fluid discharge at the extension site.The patient remains in recovery, and antibiotic therapy was initiated to manage the infection.The hospital has retained the explanted devices, and they will not be returned for analysis.
Additional Manufacturer Narrative
The devices were retained by the facility and not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A labeling review was performed on the device's instructions for use (ifu).There is no evidence that the device was used in a manner inconsistent with the labelled indications.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure involving complete removal of the dbs system due to infection.The patient exhibited fluid discharge at the extension site.The patient remains in recovery, and antibiotic therapy was initiated to manage the infection.The hospital has retained the explanted devices, and they will not be returned for analysis.

• 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: 22405274
• Report Number: 3006630150-2025-05178
• Device Sequence Number: 9978087
• Product Code: NHL
• UDI-Device Identifier: 08714729966395
• UDI-Public: (01)08714729966395(17)270219(10)5001779
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2025
• 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,Followup,Followup
• Report Date (Section B): 03/26/2026

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-3216-55
• Device Catalogue Number: DB-3216-55
• Device Lot Number: 5001779
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 11/13/2025; 03/03/2026
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 11/11/2025; 12/03/2025; 03/30/2026
• Date Device Manufactured: 02/19/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female