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

Model Number 3788

Device Problems Pocket Stimulation (1463); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Pain (1994); Burning Sensation (2146)

Event Date 06/06/2014

Event Type  Injury  

Event Description

It was reported, the patient experiences pain and burning at the scs ipg pocket site when stimulation is on.It was also reported, the sensation is also present while charging with stimulation on but not while charging when stimulation is off.The issue started after experiencing a fall on the ipg site.The patient has declined the reprogramming request.X-rays have been requested and patient is to consult the physician to determine the next course of action.

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 MED - NEUROMODULATION; plano TX
• Manufacturer Contact: taruna sharma ; 6901 preston rd.; plano, TX 75024 ; 9725269635
• MDR Report Key: 3946427
• MDR Text Key: 4644942
• Report Number: 1627487-2014-20024
• 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: 06/20/2014

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: 08/01/2015
• Device Model Number: 3788
• Device Lot Number: 4192438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: IMPLANT DATE:; SCS LEAD: MODEL 3228
• Patient Outcome(s): Other
• Patient Age: 40 YR