MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI CHARGING SYSTEM

Model Number	3721
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	04/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of the event is estimated.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.
Event or Problem Description
Related manufacturer reference number: 1627487-2020-04651.It was reported the patient experienced pocket heating while charging their ipg.Surgical intervention took place where the scs system was explanted at an unknown date to address the issue.

• Brand Name: EON MINI CHARGING SYSTEM
• Common Device Name: EON MINI CHARGING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10060919
• Report Number: 1627487-2020-04650
• Device Sequence Number: 16814364
• Product Code: LGW
• UDI-Device Identifier: 05414734402620
• UDI-Public: 05414734402620
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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 Expiration Date: 12/28/2012
• Device Model Number: 3721
• Device Catalogue Number: 3721
• Device Lot Number: 3562170
• 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: 04/30/2020
• Initial Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL # 3788 - IPG
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 77