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

Model Number 3788

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/03/2022

Event Type  Injury  

Event Description

It was reported that the ipg failed to establish communication with external devices.The ipg was deemed inoperable and patient lost therapy.Surgical intervention may take place to address the issue.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

An ipg reaching end of life was reported to abbott.No devices were returned for evaluation.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.Based on the information received, the device was in conformance at shipment and a single definitive root cause for the issue encountered was unable to be conclusively determined.

• 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: 13959005
• MDR Text Key: 288284219
• Report Number: 1627487-2022-01744
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402651
• UDI-Public: 05414734402651
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 5124802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other