MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number	3286
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced ineffective therapy.Diagnostics revealed high impedances on both leads.As a result, surgical intervention may be undertaken to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
Date of event and patient's weight is estimated.A patient experienced high impedances/ ineffective therapy was reported to abbott.As a result, the patient¿s leads were explanted and replaced.Therapy was restored.The device was not returned for analysis; however, a diagnostics report was received and confirms multiple contacts with high impedances.Based on the information received, the cause of the high impedances could not be conclusively determined.
Event or Problem Description
Additional information indicates surgical intervention was undertaken on 09dec2025 wherein both leads were explanted and replaced to address the issue.Effective therapy was restored post operatively.

• Brand Name: LAMITRODE S-8 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: 23606087
• Report Number: 1627487-2025-05738
• Device Sequence Number: 13223714
• Product Code: LGW
• UDI-Device Identifier: 05414734402231
• UDI-Public: (01)05414734402231(10)4215207(17)150828
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 12/22/2025

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: 08/28/2015
• Device Model Number: 3286
• Device Catalogue Number: 3286
• Device Lot Number: 4215207
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2013
• 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 IPG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 91 KG