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

Model Number	3716
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient did not recharge the ipg as recommended.In turn, the ipg became inoperable.Surgical intervention was undertaken wherein ipg as explanted and replaced to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
The patient reported failing to charge their implant properly to abbott.The device has not been returned for error analysis.A review of documentation supplied with the implant states that the implant must be charged every 30 days to avoid battery depletion.Based on the information received, the cause of the reported incident is consistent with user error.In an update it was reported surgery took place where the original eon ipg and octrode leads were replaced with a new full proclaim plus system.Both leads were replaced due to not knowing impedance status or integrity.The physician elected to replace everything so that they would have a completely new system.

• Brand Name: EON RECHARGEABLE IPG, 16-CHANNEL
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21043872
• Report Number: 1627487-2024-12953
• Device Sequence Number: 8433588
• Product Code: LGW
• UDI-Device Identifier: 05414734402583
• UDI-Public: (01)05414734402583(10)56873(17)080801
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 08/01/2008
• Device Model Number: 3716
• Device Catalogue Number: 3716
• Device Lot Number: 56873
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2006
• 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 LEAD X2
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 113 KG