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	10/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.E1 - reporter phone number: (b)(6).
Event or Problem Description
It was reported patient had high impedances on the lead and stopped charging the ipg.Patient lost effective stimulation as a result.To address the issue, surgical intervention was undertaken wherein the lead and ipg were explanted and replaced.Therapy was restored post-op.
Additional Manufacturer Narrative
The complaint of lack of stimulation against the returned lead was not confirmed.As received, visual inspection of the returned lead found the some of the stimulation end electrodes damaged and the wires broken.The cause of the damage is consistent with explant damage.Manufacturing investigation: material was not returned; the allegation was not unable to be confirmed or not confirmed.As shipped, the material had been manufactured, tested, packaged, and sterilized according to the current manufacturing specifications and passed all manufacturing test, visual inspection, and sterilization requirements.

• 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: 23442435
• Report Number: 1627487-2025-05071
• Device Sequence Number: 8552818
• Product Code: LGW
• UDI-Device Identifier: 05414734402231
• UDI-Public: (01)05414734402231(10)7419850(17)220311
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 03/11/2022
• Device Model Number: 3286
• Device Catalogue Number: 3286
• Device Lot Number: 7419850
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2020
• 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: Unknown