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

Model Number	NM-3138-55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erosion (1750); Impaired Healing (2378)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7104456.Udi: (b)(4).
Event or Problem Description
It was reported that a patient implanted with a deep brain stimulation (dbs) system experienced post-operative healing complications, including tissue erosion at the incision site located behind the left ear.The patient was treated with antibiotics.A revision procedure has been planned, and the event remains ongoing and under clinical assessment.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).
Event or Problem Description
It was reported that a patient implanted with a deep brain stimulation (dbs) system experienced post-operative healing complications, including tissue erosion at the incision site located behind the left ear.The patient was treated with antibiotics.A revision procedure has been planned, and the event remains ongoing and under clinical assessment.
Event or Problem Description
It was reported that a patient implanted with a deep brain stimulation (dbs) system experienced post-operative healing complications, including tissue erosion at the incision site located behind the left ear.The patient was treated with antibiotics.A revision procedure has been planned, and the event remains ongoing and under clinical assessment.Additional information was received that the patient presented with the extension protruding from the skin.The patient then underwent an explant procedure wherein the left extension and associated implantable pulse generator (ipg) were explanted.A new extension was implanted and connected to an existing ipg.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7104456.Udi: (b)(4).Product family: dbs-ipg-r-mri.Upn: m365db12160.Model: db-1216.Serial: unk.Batch: unk.Udi: unk.
Event or Problem Description
It was reported that a patient implanted with a deep brain stimulation (dbs) system experienced post-operative healing complications, including tissue erosion at the incision site located behind the left ear.The patient was treated with antibiotics.A revision procedure has been planned, and the event remains ongoing and under clinical assessment.Additional information was received that the patient presented with the extension protruding from the skin.The patient then underwent an explant procedure wherein the left extension and associated implantable pulse generator (ipg) were explanted.A new extension was implanted and connected to an existing ipg.Additional information was received that the patient is healing.
Additional Manufacturer Narrative
Correction to initial report in section: h11.Block b3: approximated based on the date the manufacturer became aware of the event.Block d.2b; additional applicable product codes: mhy and pjs.Additional suspect medical device component involved in the event: product family: dbs-extension upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7104456, udi: (b)(4).Product family: dbs-ipg-r-mri upn: m365db12160, model: db-1216, serial: (b)(6), batch: 546826, udi: (b)(4).

• Brand Name: NA
• 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: 22668564
• Report Number: 3006630150-2025-05984
• Device Sequence Number: 11718584
• Product Code: NHL
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)230720(10)7090324
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/25/2026

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: 07/20/2023
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7090324
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 11/13/2025; 01/27/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/23/2025; 12/09/2025; 02/25/2026
• Date Device Manufactured: 07/20/2021
• 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: 68 YR
• Patient Sex: Male