MAUDE Adverse Event Report: St. Jude Medical - Neuromodulation (Puerto Rico, LLC) Octrode Trial Lead Kit, 60cm Length; SCS Trial Lead

Model Number	3086
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a trial procedure on (b)(6) 2026 the patient experienced pain and the procedure could not be continued.As a result, the trial was abandoned.Following discontinuation of the trial, the pain resolved.
Additional Manufacturer Narrative
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 Trial Lead Kit, 60cm Length
• Common Device Name: SCS Trial Lead
• Manufacturer (Section D): St. Jude Medical - Neuromodulation (Puerto Rico, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): St. Jude Medical - Neuromodulation (Puerto Rico, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; +1(972)309-8000
• MDR Report Key: 50383201
• Report Number: 3006705815-2026-05276
• Device Sequence Number: 9789110
• Product Code: LGW
• UDI-Device Identifier: 05414734401555
• UDI-Public: (01)05414734401555(10)A000189284(17)280627
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/21/2026

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 Model Number: 3086
• Device Catalogue Number: 3086
• Device Lot Number: A000189284
• 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: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2026
• 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: Male
• Patient Weight: 160 LB