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

Model Number 3716

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Device 1 of 2.Related manufacturer reference number: 1627487-2019-07264.It was reported that the patient has been experiencing a heating sensation while charging their device.As a result, surgical intervention may take place to address this issue.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

Device 1 of 2.Related manufacturer reference number: 1627487-2019-07264.It was reported that the patient underwent surgical intervention on (b)(6)2019, wherein the patient's ipg was explanted and replaced.

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.

Event Description

Device 1 of 2.Related manufacturer reference number: 1627487-2019-07264.

• Brand Name: EON RECHARGEABLE IPG, 16-CHANNEL
• 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: 8725525
• MDR Text Key: 148909701
• Report Number: 1627487-2019-07261
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402583
• UDI-Public: 05414734402583
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 3716
• Device Catalogue Number: 3716
• Device Lot Number: 3554266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/07/26/2012/001-C
• Patient Sequence Number: 1
• Treatment: SCS CHARGER
• Patient Outcome(s): Other
• Patient Weight: 43