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

Model Number	3721
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burning Sensation (2146)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.
Event or Problem Description
Related mfr report: 1627487-2021-01120.It was reported the patient complained of heating during recharge of the scs system implantable pulse generator (ipg).The patient stated the charger antenna heated up not allowing it to be placed on the skin.The next course of action has not been determined.
Additional Manufacturer Narrative
A patient experiencing heating at the ipg site while charging was reported to abbott.The patient has not elected to participate in the charger exchange program to resolve the issue.The device history record of the device was reviewed.All three batches were manufactured in 2015, and pcb with previous software design were scrapped in 2018.Refer to capa 118058 for details.Actions have been taken to prevent reoccurrence.

• Brand Name: EON MINI CHARGING SYSTEM
• Common Device Name: SCS CHARGER
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11304990
• Report Number: 1627487-2021-01121
• Device Sequence Number: 3286297
• Product Code: LGW
• UDI-Device Identifier: 05414734402620
• UDI-Public: 05414734402620
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: 10/31/2016
• Device Model Number: 3721
• Device Catalogue Number: 3721
• Device Lot Number: 5298105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 08/02/2021
• 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, SCS IPG; MODEL 3788, SCS IPG
• Outcome Attributed to Adverse Event: Other