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

Model Number 3788

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Muscle Spasm(s) (1966); Inadequate Pain Relief (2388)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

The results/ method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient and event information.Further information was requested but not received.

Event Description

It was reported the patient stopped charging the ipg due to random spasms.Surgical intervention may be pending.

Manufacturer Narrative

The directions for use 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 related to user error.

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 Description

Additional information received indicated that the ipg was explanted and replaced.Effective therapy was restored.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: 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: 10987087
• MDR Text Key: 220790120
• Report Number: 1627487-2020-48760
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402651
• UDI-Public: 05414734402651
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 3956062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 73 KG