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

Model Number	3788
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that the patient lost therapy due to ipg being inoperable.As such, surgical intervention may take place at a later date to address the issue.
Event or Problem Description
Additional information received indicates that the patient stopped charging the ipg a year ago, rendering the ipg inoperable.In turn, surgical intervention took place on (b)(6) 2022 wherein the ipg was explanted and replaced with a new ipg addressing the issue.Reportedly, therapy was confirmed post op.
Additional Manufacturer Narrative
The patient reported failing to charge their implant properly to abbott.The device has not been returned for 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.

• 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: 15130583
• Report Number: 1627487-2022-04172
• Device Sequence Number: 5399245
• Product Code: LGW
• UDI-Device Identifier: 05414734402736
• UDI-Public: 05414734402736
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2022

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: 11/28/2013
• Device Model Number: 3788
• Device Catalogue Number: 3851
• Device Lot Number: 3537868
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 10/12/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/01/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2011
• 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 ANCHOR (X2); SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 95 KG