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

Model Number	3716
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
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.Date of event is estimated.
Event or Problem Description
It was reported that the patient's ipg was inoperable.As a result, the physician explanted and replaced the patient's ipg.Surgical intervention resolved 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
• MDR Report Key: 12648297
• Report Number: 1627487-2021-17780
• Device Sequence Number: 1205006
• Product Code: LGW
• UDI-Device Identifier: 05414734402736
• UDI-Public: 05414734402736
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

1 Device 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 Expiration Date: 11/28/2011
• Device Model Number: 3716
• Device Catalogue Number: 3851
• Device Lot Number: 2882112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No