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

Model Number	3721
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
Additional information indicates surgical intervention was undertaken on (b)(6) 2021 wherein the ipg was explanted and replaced.Issue resolved.
Additional 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.
Additional 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
• Common Device Name: IPG CHARGING SYSTEM
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10928244
• Report Number: 1627487-2020-48438
• Device Sequence Number: 910295
• Product Code: LGW
• UDI-Device Identifier: 05414734402620
• UDI-Public: 05414734402620
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 01/11/2021; 01/29/2021; 02/28/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/11/2021; 02/08/2021; 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1627487/07/26/2012/001-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS IPG.; SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Weight: 95