MAUDE Adverse Event Report: ABBOTT MEDICAL EON MINI¿ LE CHARGING SYSTEM; SCS CHARGER

Model Number	3722
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is estimated.The reported event of the charger burning and smoking was not confirmed.As received, visual inspection showed the returned charger had no burning smell or damage on the circuit board.The cause of the reported event remains unknown.
Event or Problem Description
It was reported that the patient's charger was smoking and had a burning smell.In turn, the nurse gave the patient a new charger, resolving the issue.
Additional Manufacturer Narrative
Date of event is estimated.The reported event of the charger burning and smoking was not confirmed.As received, visual inspection showed the returned charger had no burning smell or damage on the circuit board.The cause of the reported event remains unknown.
Event or Problem Description
It was reported that the patient's charger was smoking and had a burning smell.In turn, the nurse gave the patient a new charger, resolving the issue.

• Brand Name: EON MINI¿ LE CHARGING SYSTEM
• Common Device Name: SCS CHARGER
• 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: 13552334
• Report Number: 1627487-2022-00948
• Device Sequence Number: 20133658
• Product Code: LGW
• UDI-Device Identifier: 05414734405300
• UDI-Public: 05414734405300
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2017
• Device Model Number: 3722
• Device Catalogue Number: 3722
• Device Lot Number: 5562452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• 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: 02/16/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2016
• 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
• Patient Sex: Unknown