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

Model Number 3788

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Scar Tissue (2060); Tingling (2171); Discomfort (2330)

Event Date 03/01/2014

Event Type  Injury  

Event Description

It was reported the pt experienced an uncomfortable stinging sensation at the ipg site when charging.The pt reported there is quite a bit of scar tissue over the ipg, but the area is not swollen or red.Reportedly the pt has not fallen or had trauma to the area.The pt does not plan any intervention at this time.

Manufacturer Narrative

Correction number: 1627487-07262012-002-r.This ipg serial number was included in field advisories.Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: EON MINI
• 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
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 3710517
• MDR Text Key: 17612176
• Report Number: 1627487-2014-12222
• 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: Consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2011
• Device Model Number: 3788
• Device Lot Number: 2880148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Treatment: SCS EXTENSION: MODEL 3341 (2); SCS LEADS: MODEL 3149 (4); IMPLANT DATE:; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 44 YR