MAUDE Adverse Event Report: ABBOTT MEDICAL EON RECHARGEABLE IPG, 16-CHANNEL; SCS IPG

Model Number	3716
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.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.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.
Event or Problem Description
It was reported that the patient experienced ineffective therapy due to the lead being implanted at a suboptimal level.Additionally, the patient ipg was inoperable.As such, surgical intervention took place wherein the devices were explanted to address the issue.

• Brand Name: EON RECHARGEABLE IPG, 16-CHANNEL
• Common Device Name: SCS IPG
• 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: 22003590
• Report Number: 1627487-2025-02325
• Device Sequence Number: 9115064
• Product Code: LGW
• UDI-Device Identifier: 05414734402583
• UDI-Public: 05414734402583
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2025

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 Model Number: 3716
• Device Catalogue Number: 3716
• 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: 04/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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