MAUDE Adverse Event Report: ABBOTT MEDICAL EON MINI IPG, 16-CHANNEL RECHARGEABLE; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	3788
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient got a post-operative infection and the ipg was explanted to address the issue at in (b)(6) 2025.The infection persisted and as such, the patient returned for surgery on (b)(6) 2025 where the prior ipg pocket was washed out and the lead was explanted due to back pain.
Additional Manufacturer Narrative
Date of the event is estimated.Date of the explant is estimated.During processing of this incident, attempts were made to obtain complete patient information.
Additional Manufacturer Narrative
The reported issue for ¿infection¿ cannot be confirmed through product analysis testing.Analysis of the lead found it was returned incomplete.The lead was cut during the explant procedure and only the stimulation (paddle) end segment was returned.Continuity was tested from contacts to corresponding bare wires and no opens were found.The device history record was reviewed to ensure proper packaging and sterility.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.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 24472136
• Report Number: 1627487-2026-00927
• Device Sequence Number: 18552825
• Product Code: LGW
• UDI-Device Identifier: 05414734402651
• UDI-Public: (01)05414734402651(10)2816188(17)110628
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 05/29/2026

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: 06/28/2011
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 2816188
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2009
• 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 Age: 51 YR
• Patient Sex: Male
• Patient Weight: 91 KG