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

Model Number 3788

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 11/01/2013

Event Type  Injury  

Event Description

It was reported that the patient is experiencing uncomfortable heating at her scs ipg pocket site at all times.It was also reported initially, the issue would resolve upon turning the scs ipg off but now remains regardless of whether the device is turned on or off.Follow-up identified the physician determined fluid intrusion has occurred in the scs ipg header.Surgical intervention will be taken at a later date to address the issue.

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.

• Brand Name: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST JUDE MEDICAL NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston rd.; plano, TX 75024 ; 9725264637
• MDR Report Key: 3900102
• MDR Text Key: 4672732
• Report Number: 1627487-2014-03365
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: 3788
• Device Lot Number: 3935078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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 ANCHOR: MODEL 1192 (2),; SCS LEAD: MODEL 3186 (2),; IMPLANT DATE:; IMPLANT DATE:
• Patient Age: 46 YR