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

Model Number	3186
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received indicated that the patient underwent a revision procedure.Intraoperative testing revealed all 16 lead contacts were invalid.An attempt was made to replace the leads; however, the physician was unable to advance the replacement leads within the epidural space.Consequently, the procedure was aborted, and the system was removed.No further information has been provided.

• 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: 50949687
• Report Number: 1627487-2026-10392
• Device Sequence Number: 10429260
• Product Code: LGW
• UDI-Device Identifier: 05414734401708
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 09/30/2026

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: 06/28/2013
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 3410881
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2011
• 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: Female
• Patient Weight: 160 LB