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

Model Number	3688
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Discomfort (2330); Post Operative Wound Infection (2446)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an infection was present at the ipg site.Surgical intervention took place on (b)(6) 2022 and in which the patient had their ipg revised and irrigated.Effective therapy was restored.
Event or Problem Description
Patient had system explanted on 17jan2023 due to ipg site discomfort.
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.

• Brand Name: EON C 16-CHANNEL IPG
• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15762868
• Report Number: 1627487-2022-06149
• Device Sequence Number: 20890127
• Product Code: LGW
• UDI-Device Identifier: 05414734402460
• UDI-Public: 05414734402460
• 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: 2012
• Device Explanted Year: 2023
• 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): 02/14/2023

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: 05/28/2013
• Device Model Number: 3688
• Device Catalogue Number: 3688
• Device Lot Number: 3389111
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 02/08/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 02/07/2023; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2011
• 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 X1; SCS EXTENSION X1; SCS LEADS X 3
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 79 KG