MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number	3189
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Failure of Implant (1924); Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced painful/shocking stimuli and the strength of the therapy was decreasing on its own.Impedance check revealed that on of the leads has high impedances.Reprogramming was able to able to obtain therapy in the painful areas.Surgical intervention may take place a later date to address the issue.Investigation was unable to determine which of the leads attributed to the issue.
Additional Manufacturer Narrative
Date of event is estimated.Additional components potentially involved in the event include: common device name: scs lead, model:3189, udi :(b)(4), serial: (b)(6), batch:4735803.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Corrected data: b5 in the initial report should have been "impedance check revealed that one of the leads has high impedances.Reprogramming was able to obtain therapy in the painful areas.".
Event or Problem Description
Additional information received indicates that surgical intervention took place on (b)(6) 2025 for an elective ipg replacement.Nothing was done to the lead.Reportedly, manufacturer was able to reprogram around the contacts with high impedance to address the issue.The system is functioning properly with no issue.Complete coverage was achieved.

• Brand Name: OCTRODE LEAD KIT, 90CM 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21163095
• Report Number: 1627487-2025-00255
• Device Sequence Number: 9355558
• Product Code: LGW
• UDI-Device Identifier: 05414734406147
• UDI-Public: (01)05414734406147(10)4735803(17)160828
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 02/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 4735803
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2014
• 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: 91 KG