MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI CHARGING SYSTEM; SCS CHARGER

Model Number	3721
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	09/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This charger model was associated with a field correction.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Reference mfr.Report#: 1627487-2019-10347.It was reported that the patient¿s ipg is warming up while it is recharging.On 01 august 2012 st.Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients.An increase in prior non-reported heating while charging events and other non-reported events was expected.
Additional Manufacturer Narrative
A patient reported experiencing pocket site heating while charging.The patient has not exchanged his old charger for an upgraded model.Actions have been taken to prevent reoccurrence.

• Brand Name: EON MINI CHARGING SYSTEM
• Common Device Name: SCS CHARGER
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9000766
• Report Number: 1627487-2019-10348
• Device Sequence Number: 2181765
• Product Code: LGW
• UDI-Device Identifier: 05414734402620
• UDI-Public: 05414734402620
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 07/31/2016
• Device Model Number: 3721
• Device Catalogue Number: 3721
• Device Lot Number: 5194978
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: 1627487-07262012-001-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS IPG