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

Model Number 3721

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number:1627487-2020-48437.It was reported that the patient experienced some weight loss followed by pocket heating while using a high energy charger.Reportedly, the ipg ceased functioning following the incident.As a result, surgical intervention may be undertaken in the future.

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.

Event Description

Additional information indicates surgical intervention was undertaken on (b)(6) 2021 wherein the ipg was explanted and replaced.Issue resolved.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.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.

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.

• Brand Name: EON MINI CHARGING SYSTEM
• Type of Device: IPG CHARGING SYSTEM
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10928244
• MDR Text Key: 218958835
• Report Number: 1627487-2020-48438
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402620
• UDI-Public: 05414734402620
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2011
• Device Model Number: 3721
• Device Catalogue Number: 3721
• Device Lot Number: 3111856
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 01/11/2021; 01/29/2021; 02/28/2021
• Supplement Dates FDA Received: 01/11/2021; 02/08/2021; 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/07/26/2012/001-C
• Patient Sequence Number: 1
• Treatment: SCS IPG.; SCS IPG
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 95