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

Model Number 3788

Device Problems No Device Output (1435); Inappropriate/Inadequate Shock/Stimulation (1574); Temperature Problem (3022)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)

Event Date 01/01/2010

Event Type  Injury  

Event Description

Device 1 of 3.Ref mfr report: 1627487-2014-06123 and 1627487-2014-06214.The pt has two leads implanted with the same lot number.It was reported the pt experienced a shocking and heating sensation at the ipg site while charging.The pt also reported pain and swelling at the implant site.The pt stopped using his scs system in 2010 due to reported issues and it requesting to have the scs system removed.On 08/01/2012 st.Jude medical, neuromodulation division, sent field action letters to pts related to heating while charging adn raised awareness of this issue to pts.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 advisory and 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 MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: kimberly goode ; 6901 preston rd.; plano, TX 75024 ; 9723098541
• MDR Report Key: 4060863
• MDR Text Key: 17999890
• Report Number: 1627487-2014-06212
• 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: Other
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2011
• Device Model Number: 3788
• Device Lot Number: 2831145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• 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
• Patient Age: 43 YR