MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON; SCS IPG

Model Number 3716

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 12/10/2014

Event Type  Injury  

Event Description

Follow up information identified the patient is not experiencing discomfort.The patient has always experienced warmth with both the charging systems.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Event Description

Device #1 of 2.Reference mfr.Report: 1627487-2014-22057.It was reported the patient was undergoing surgical intervention to replace her ipg (reference mfr.Report: 1627487-2014-08523).Pre-operatively the patient reported she experienced warmth while recharging.In addition, it is unknown if she was also experiencing discomfort.On 08/01/2012 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.

Manufacturer Narrative

This ipg serial number was included in a field correction.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: EON
• 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; st. jude medical neuromodulation division; 6901 preston road; plano TX 75024
• MDR Report Key: 4372081
• MDR Text Key: 5570401
• Report Number: 1627487-2014-22056
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

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: 03/31/2009
• Device Model Number: 3716
• Device Lot Number: 68514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-001-C
• Patient Sequence Number: 1
• Treatment: MODEL 3383 (2), SCS EXTENSION; MODEL 3228, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 49 YR