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

Model Number 3788

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discharge (2225); Post Operative Wound Infection (2446)

Event Date 02/22/2013

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report#: 1627487-2014-05427.It was reported the patient experienced an infection following being implanted on (b)(6) 2014, the treatment for the infection is unknown.On (b)(6) 2014, the patient underwent a procedure to have an additional scs system implanted for a new pain pattern.During the procedure, pus and an infection were found at the ipg site of the first scs system.As a result, the doctor cleaned the pocket site and soaked the ipg in betadine.Next, the doctor placed the ipg back in it's original location.The patient will follow-up with his doctor and will be given antibiotics.

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: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 3891836
• MDR Text Key: 22261656
• Report Number: 1627487-2014-05426
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Model Number: 3788
• Device Lot Number: 3908463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 36 YR