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 Code	Erosion (1750)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7123001.Product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7122879.Product family: dbs-linear leads.Upn: m365db220145dc0.Model: db-2201-45dc.Serial: (b)(6).Batch: 7072513.Product family: dbs-ipg-r-mri.Upn: m365db12160.Model: db-1216.Serial: (b)(6).Batch: 585698.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced erosion at the header block of the lead extension and underwent a full system explant.The patient is doing well postoperatively.The devices were discarded.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced erosion at the header block of the lead extension and underwent a full system explant.The patient is doing well postoperatively.The devices were discarded.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4605-c.Batch: 32118923.Product family: dbs-lead fixation.Upn: m365db4605c0.Model: db-4605-c.Batch: 29206351.Product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4605-c.Batch: 32546120.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced erosion at the header block of the lead extension and underwent a full system explant.The patient is doing well postoperatively.The devices were discarded.Additional information was received that the implantable pulse generator (ipg) was collected and will be sent out for analysis.

• 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: 20850148
• Report Number: 3006630150-2024-08387
• Device Sequence Number: 3730429
• Product Code: PJS
• UDI-Device Identifier: 08714729836544
• UDI-Public: 08714729836544
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 03/03/2025

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: 08/15/2025
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 7074271
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 02/06/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/04/2025; 03/03/2025
• Date Device Manufactured: 08/16/2023
• 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: 87 YR
• Patient Sex: Male
• Patient Race: White