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

Model Number	3721
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The charger was included in a field correction.Date of event is estimated.The investigation for capa (b)(4) associated with heating while charging (pocket heating) concluded that the charger was capable of transferring energy to the ipg at a rate that would cause heating of the ipg and/or charging wand of sufficient elevated temperature to cause pain and burns.The heating while charging was determined to be exacerbated by off-axis charging of shallow implanted ipgs and that all chargers were capable of elevated heating.
Event or Problem Description
Related manufacturer reference number: 1627487-2020-03556.It was reported the patient experienced pocket heating while charging the ipg.As a result, the ipg was explanted.The date of explant is unknown.The system was also explanted due to ineffective stimulation as documented in related manufacturer reference numbers 1627487-2020-03665 and 1627487-2020-03666.
Additional Manufacturer Narrative
Added the checkmark that was inadvertently left off the initial report.During processing of this complaint, patient weight and complete event information were not requested due to patient not consenting to further contact.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: CHARGING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9975561
• Report Number: 1627487-2020-03557
• Device Sequence Number: 3881697
• Product Code: LGW
• UDI-Device Identifier: 05414734402620
• UDI-Public: 05414734402620
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 11/28/2010
• Device Model Number: 3721
• Device Catalogue Number: 3721
• Device Lot Number: 2884241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR