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

Model Number	3189
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Skin Erosion (2075)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight is estimated.Additional components potentially involved in the event include: common device name: scs lead, model: 3189, udi:(b)(4), serial: (b)(6), batch:4930632.
Event or Problem Description
It was reported that the patient¿s left occipital lead (contact) was exposed/skin erosion and experienced an infection.Patient had irritation, redness and drainage (pus) at left lead site.Patient was prescribed antibiotics by their pcp.Subsequently.Surgical intervention took place wherein the surgeon explanted the entire system to address the issue.Reportedly, there were no further signs of infection during the explant.Patient continued to use antibiotics to address the issue.Investigation was unable to determine which if the leads is the left lead.
Additional Manufacturer Narrative
A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Event or Problem Description
Additional information received indicates that the patient went through iv antibiotic treatment to address the issue.

• 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: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 24779823
• Report Number: 1627487-2026-01611
• Device Sequence Number: 17658486
• Product Code: LGW
• UDI-Device Identifier: 05414734406147
• UDI-Public: (01)05414734406147(10)4930632(17)170128
• 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
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 05/01/2026

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: 01/28/2017
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 4930632
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/28/2026; 04/29/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/30/2026; 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2015
• 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; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 94 KG