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 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information was requested but unable to obtain.

Event Description

Related manufacturer reference number:1627487-2019-08727.It was reported that the patient experienced heating sensation at the ipg pocket site only when recharging the ipg since a few months.As such, a replacement charging system was provided to the patient.Unknown if the issue was addressed with the new charging system at time.On (b)(6) 2012 st.Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients.An increase in prior non-reported heating while charging events and other non-reported events was expected.

Event Description

Follow-up information received indicates that the replacement charging system did not resolve the issue.Patient will be meeting with the physician at a later date to determine the next course of action to address the issue.

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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8855858
• MDR Text Key: 153118963
• Report Number: 1627487-2019-08726
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402651
• UDI-Public: 05414734402651
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 3788
• Device Lot Number: 3867387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2012
• 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
• Treatment: SCS CHARGER
• Patient Outcome(s): Other