MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

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

Patient Problem Skin Irritation (2076)

Event Date 03/24/2014

Event Type  Injury  

Event Description

It was reported the patient is sensitive and allergic to multiple things, at this time the patient has been implanted with a scs system for approximately seven months and appears to have developed some kind of allergy, however, it is unknown at this time if it may be related to the scs system.Follow-up identified that according to the patient the allergist has not reached any conclusions.The allergist started the patient on medication to see if it helps clear the rash.The patient will follow-up in 30-60 days.Additional follow-up identified the patient underwent surgical intervention and had her scs ipg wrapped in two ipg allergy pouches.

Manufacturer Narrative

(b)(4).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 IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4748635
• MDR Text Key: 16854388
• Report Number: 1627487-2015-01177
• 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: Other
• Type of Report: Initial
• Report Date: 04/09/2015

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?: No
• Device Operator: Other
• Device Expiration Date: 04/28/2015
• Device Model Number: 3788
• Device Lot Number: 4047205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2013
• 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: MODEL 1192 (X2), SCS ANCHOR; MODEL 3186 (X2), SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 70 YR