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

Model Number 3688

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Discomfort (2330); Post Operative Wound Infection (2446)

Event Date 10/19/2022

Event Type  Injury  

Event 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 Description

Patient had system explanted on 17jan2023 due to ipg site discomfort.

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
• Type of Device: 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
• MDR Text Key: 303352468
• Report Number: 1627487-2022-06149
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402460
• UDI-Public: 05414734402460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR X1; SCS EXTENSION X1; SCS LEADS X 3
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 79 KG