MAUDE Adverse Event Report: ABBOTT MEDICAL EON MINI CHARGING SYSTEM

Model Number	3721
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	06/07/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
¿date of event¿ is estimated.During processing of this complaint, patient weight and complete event information were not requested due to patient not consenting to further contact.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.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: 1627487-2020-32201.It was reported that patient experienced ipg pocket heating while charging ipg.As a result, surgery occurred during which the ipg was explanted.The date of explant is unknown.
Additional Manufacturer Narrative
It was reported to abbott that the patient experienced extreme heating while charging system.The patient reported in (b)(6) 2013 that he experienced extreme heating while charging so patient has stopped using the device and wanted to be explanted.Both leads and ipg were explanted without replacement (b)(6) 2012 due to pocket heating.The results of the investigation are inconclusive, and the root cause of the reported incident is unknown as the device was not returned for analysis.

• Brand Name: EON MINI CHARGING SYSTEM
• Common Device Name: CHARGING SYSTEM
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10668162
• Report Number: 1627487-2020-32202
• Device Sequence Number: 2880899
• 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: company representative,consum
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2020

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: 11/28/2012
• Device Model Number: 3721
• Device Catalogue Number: 3721
• Device Lot Number: 3552290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 12/20/2020
• 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