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

Model Number	NM-3138-55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patients lead extension protruded through the skin at the implantable pulse generator (ipg) site.The physician did not want to risk an infection; therefore, the patient underwent an explant procedure to remove the dbs system.The explanted devices will not be returned as the local representative was not present for the procedure to retrieve them.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in (b)(6) 2021 additional suspect medical device component involved in the event: product family: dbs-ipg-pc upn: m365db14080 model: db-1408 serial: (b)(6) batch: 203511 udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient's lead extension protruded through the skin at the implantable pulse generator (ipg) site.The physician did not want to risk an infection therefore; the patient underwent an explant procedure to remove the dbs system.The explanted devices will not be returned as the local representative was not present for the procedure to retrieve them.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in december 2021 additional suspect medical device component involved in the event: product family: dbs-ipg-pc upn: m365db14080, model: db-1408, serial: (b)(6), batch: 203511, udi: (b)(4).

• 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; 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: 23751532
• Report Number: 3006630150-2025-11277
• Device Sequence Number: 5892713
• Product Code: PJS
• UDI-Device Identifier: 08714729820765
• UDI-Public: (01)08714729820765(17)230916(10)7092559
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 02/16/2026

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 Expiration Date: 09/16/2023
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7092559
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 09/16/2021
• 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: 76 YR
• Patient Sex: Female