MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI CHARGING SYSTEM; SCS CHARGING SYSTEM

Model Number 3721

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problem No Information (3190)

Event Date 12/24/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report: 1627487-2015-21042.It was reported the patient ((b)(6)) experienced pocket heating at the ipg site while charging.The patient declined using a replacement charging system and expressed wanting the scs system explanted.On 8/1/2012 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.The implant date for the following concomitant devices is unknown at this time: model 3156 and 3153(2), scs leads.

• Brand Name: EON MINI CHARGING SYSTEM
• Type of Device: SCS CHARGING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, tx
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4495481
• MDR Text Key: 5504158
• Report Number: 1627487-2015-21041
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• Device Model Number: 3721
• Device Lot Number: 3433706
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other