MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number	3186
Medical Device Problem Codes	Low impedance (2285); Impedance Problem (2950)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead; therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: octrode lead kit, 60cm length, model: 3186, udi: (b)(4), serial: (b)(6), batch: 4915070.
Event or Problem Description
It was reported that the system has impedances.Reprogramming was unable to restore effective therapy.Surgical intervention may take place in the future to address the issue.It is unknown which lead caused / contributed to the event.
Event or Problem Description
Additional information was obtained stating both leads had invalid impedances.
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.
Event or Problem Description
Additional information was obtained that the leads are no longer reportable.No intervention was taken on the leads, and effective therapy was established through reprogramming.

• 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 ; 9723098000
• MDR Report Key: 22976995
• Report Number: 1627487-2025-04426
• Device Sequence Number: 8937828
• Product Code: LGW
• UDI-Device Identifier: 05414734406130
• UDI-Public: (01)05414734406130(10)4915070(17)161228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/08/2026

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: 12/28/2016
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 4915070
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 11/06/2025; 06/04/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/09/2025; 11/06/2025; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2014
• 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); SCS IPG; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 68 KG