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

Model Number	3688
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient's ipg was unable to communicate with external devices and the patient lost therapy.A manufacturer representative confirmed the issue.As a result, surgical intervention may be pending to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.(b)(6).
Event or Problem Description
Additional information received indicate the patient underwent surgical intervention wherein the ipg was explanted and replaced to address the issue.
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.
Additional Manufacturer Narrative
An ipg replacement due to ineffective stimulation was reported to abbott.The system in question was not returned for evaluation.As a result, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances present that could have contributed to this issue.Based on the information received, the device was in conformance at shipment and a single definitive root cause for the issue encountered was unable to 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: 15491005
• Report Number: 1627487-2022-05166
• Device Sequence Number: 1885864
• Product Code: LGW
• UDI-Device Identifier: 05414734402460
• UDI-Public: 05414734402460
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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): 12/16/2022

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: 12/13/2019
• Device Model Number: 3688
• Device Catalogue Number: 3688
• Device Lot Number: 6235145
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 11/10/2022; 12/14/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 12/06/2022; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2017
• 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