MAUDE Adverse Event Report: Abbott Medical Octrode Lead Kit, 60cm Length; SCS Lead

Model Number	3186
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	09/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's ipg site opened and the system was protruding.As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the system was explanted to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .

• Brand Name: Octrode Lead Kit, 60cm 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: 50937941
• Report Number: 1627487-2026-10376
• Device Sequence Number: 13451832
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 03/01/2018
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 5406095
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCS Anchor (x2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 250 LB