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

Model Number 3788

Device Problems Improper or Incorrect Procedure or Method (2017); Wireless Communication Problem (3283)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

It was reported the patients ipg is inoperable and no longer communicates with external devices.Surgical intervention may be pending to address the issue.

Manufacturer Narrative

An inoperable implant due to possibly not charging the device was reported to abbott, but could not be confirmed.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
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12490675
• MDR Text Key: 271986118
• Report Number: 1627487-2021-17082
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402651
• UDI-Public: 05414734402651
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 3531723
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other