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

Model Number	3086
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Implant Pain (4561)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported following a trial procedure on (b)(6) 2026 the patient experienced significant pain resulting in a fall and the patient needing stitches.Surgical intervention took place wherein the trial system was explanted to address the issue.Note: it is unknown which lead is related to this issue.
Additional Manufacturer Narrative
The allegation is against 1 of 2 octrode lead kit, 60cm length; however, it is unknown which octrode lead kit, 60cm length, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: octrode lead kit, 60cm length, model: 3086ans, udi: (b)(4), serial: (b)(6), batch: a000189940.
Additional Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

• Brand Name: Octrode Trial Lead Kit, 60cm Length
• Common Device Name: SCS 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: 50936454
• Report Number: 3006705815-2026-06104
• Device Sequence Number: 15834160
• Product Code: LGW
• UDI-Device Identifier: 05414734401555
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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 Model Number: 3086
• Device Catalogue Number: 3086
• Device Lot Number: A000189940
• 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: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCS Lead
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 90 LB