MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

Event date is estimated.Further information requested but not available.The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

It was reported patient experienced burring sensation at the pocket site when charging for long.Surgical intervention may be addressed to address this issue.

Event Description

Additional information indicates surgical intervention was undertaken on (b)(6) 2020 wherein the system was explanted.Issue resolved.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10399418
• MDR Text Key: 202673407
• Report Number: 1627487-2020-23944
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 4150503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 91