MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS EON MINI

Model Number 3788

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Pain (1994); Weight Changes (2607)

Event Date 10/16/2014

Event Type  Injury  

Event Description

It was reported the patient has lost a significant amount of weight.As a result, the ipg is moving around in the pocket thereby causing persistent pain at the ipg site.Reportedly, the patient presented to the er on (b)(6) 2014 due to the issue.Follow-up identified surgical intervention was undertaken, explanting and replacing the ipg with a new model.Effective coverage was achieved postoperatively.The issue is resolved.

Manufacturer Narrative

This ipg serial number was included in field advisory.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
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS; plano TX
• Manufacturer Contact: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 4360248
• MDR Text Key: 5116107
• Report Number: 1627487-2014-01831
• 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: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2013
• Device Model Number: 3788
• Device Lot Number: 3804043
• Other Device ID Number: 05414734402620
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS ANCHOR, MODEL 1192 (2),; SCS LEAD, MODEL 3186(2),; IMPLANT DATE:
• Patient Outcome(s): Hospitalization
• Patient Age: 20 YR