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

Model Number 3721

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.

Event 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.

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
• Type of Device: SCS CHARGER
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11304990
• MDR Text Key: 231107018
• Report Number: 1627487-2021-01121
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402620
• UDI-Public: 05414734402620
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3788, SCS IPG; MODEL 3788, SCS IPG
• Patient Outcome(s): Other