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

Model Number 3788

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670); Low impedance (2285)

Patient Problems Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)

Event Date 01/11/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report # 1627487-2014-01202.It was reported the pt discontinued use and charging of the scs system for approximately 3 months after implant.Recently, uncomfortable stimulation was felt in different areas of the pt's body.The pt would like the ipg removed and the lead may remain implanted.Follow-up revealed impedances were normal on some contacts and low on others.Previous programs were deleted and turned off magnet mode.Surgical intervention may occur at a future date.

Manufacturer Narrative

Correction number: 1627487-12192011-003-r.This ipg serial number was included in field advisories.Sjm has limited information 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; plano TX
• Manufacturer Contact: melissa nkematu ; 6901 preston road; plano, TX 75024 ; 9723092520
• MDR Report Key: 3733417
• MDR Text Key: 4307448
• Report Number: 1627487-2014-01201
• 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: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2010
• Device Model Number: 3788
• Device Lot Number: 708243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R,
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR