MAUDE Adverse Event Report: Abbott Medical Octrode Lead Kit, 90cm Length; SCS Lead

Model Number	3189
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Swelling/ Edema (4577)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inflammation (swelling/redness) at the lead site.As such, surgical intervention took place (b)(6) 2026 wherein the doctor cut and removed the portion of the lead that was under the affected area.The remaining portion of the lead remains implanted and connected to the ipg(related manufacturer reference number: 1627487-2026-10157).
Additional Manufacturer Narrative
Date of event is estimated.

• Brand Name: Octrode Lead Kit, 90cm Length
• Common Device Name: SCS Lead
• Manufacturer (Section D): Abbott Medical; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): Abbott Medical; 6901 preston rd; plano TX 75024
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; +1(972)309-8000
• MDR Report Key: 50829586
• Report Number: 1627487-2026-10156
• Device Sequence Number: 8652838
• Product Code: LGW
• UDI-Device Identifier: 05414734401715
• UDI-Public: (01)05414734401715(10)7400879(17)220218
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 7400879
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2020
• 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: Other
• Patient Sex: Unknown