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

Model Number 3788

Device Problems Nonstandard Device (1420); Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

(b)(4).1627487-12192011-003-r.This ipg serial number was included in field advisories.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.

Event Description

The patient has two systems implanted.This issue is regarding the thoracic scs system.The patient reported stimulation was lost sometime after (b)(6) 2015 (date of event unknown).Reportedly, the patient last recharged the system around that same time.The patient denies any falls or recent trauma.Follow-up identified the sjm representative met with the patient to evaluate the system.It was noted the ipg would not communicate with any external devices and the patient programmer displayed an error message.Surgical intervention may be undertaken as the next course of action to address the issue.

Event Description

Follow-up identified surgical intervention was undertaken during which time the ipg was explanted and replaced with a new model.Postoperative programming is pending.

Event Description

Follow-up identified postoperative programming was successful.The issue is resolved.

• 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: 5520757
• MDR Text Key: 41009514
• Report Number: 1627487-2016-01425
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2016

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: Health Professional
• Device Expiration Date: 11/28/2011
• Device Model Number: 3788
• Device Lot Number: 2884611
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/24/2016; 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other