MAUDE Adverse Event Report: ABBOTT MEDICAL EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number	3788
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient did not charge their ipg per manufacturing guidelines and therefore it became inoperable.In turn, surgical intervention may occur to address this issue.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
A review of documentation supplied with the implant states that the implant must be charged every 30 to 90 days to avoid battery depletion.Based on the information received, the cause of the reported incident is consistent with user error.
Event or Problem Description
Additional information received indicated surgical intervention occurred wherein the ipg was explanted and replaced to address the issue.
Additional Manufacturer Narrative
The directions for use states that the implant must be charged every 30 to 90 days to avoid battery depletion.Based on the information received, the cause of the reported incident is related to user error.-.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Common Device Name: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12862485
• Report Number: 1627487-2021-18583
• Device Sequence Number: 4093474
• Product Code: LGW
• UDI-Device Identifier: 05414734402736
• UDI-Public: 05414734402736
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 3788
• Device Catalogue Number: 3851
• Device Lot Number: 3584291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 01/17/2022; 07/13/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/21/2022; 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS EXTENSION X 2; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 102 KG