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 Codes	Inadequate Pain Relief (2388); Implant Pain (4561)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient stopped using and charging the device due to pain at the ipg site.As such, the ipg became inoperable.In turn, surgical intervention took place wherein the ipg was explanted and replaced with a new ipg addressing the issue.Reportedly, therapy was confirmed post op.
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Additional information received indicates that the new ipg was implanted in the same pocket and the pain at ipg site has resolved.
Additional Manufacturer Narrative
The reported event for inoperable ipg was confirmed.As received, the ipg was inoperable due to a depleted battery.Per event details, the patient had not used the system since right before the covid pandemic.The patient has a lot of pain at the ipg site.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.The ipg was functionally tested and passed all testing.According to the review of eon mini ifu/dfu, 37-1004, there is adequate information for preserving the ipg when not in use.Section ¿maintaining the ipg battery¿ in the dfu, the shaded area entitled ¿warning¿ states, ¿do not let an ipg battery remain depleted for an extended period of time.If a depleted battery is not recharged within 30 to 90 days of its full discharge, the charger may not be able to recharge it; and it will have to be surgically replaced to resume therapy.¿.

• 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: 15256468
• Report Number: 1627487-2022-04517
• Device Sequence Number: 17614020
• Product Code: LGW
• UDI-Device Identifier: 05414734402736
• UDI-Public: 05414734402736
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/21/2022

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: 09/28/2014
• Device Model Number: 3788
• Device Catalogue Number: 3851
• Device Lot Number: 3814171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 09/12/2022; 10/13/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 10/04/2022; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2012
• 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 LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 77 KG