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

Model Number 3788

Device Problems No Device Output (1435); Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Recall: 1627487-07262012-002-r, , 1627487-12192011-003-r.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.(b)(4).

Event Description

The patient reports last recharging the ipg approximately a month ago (date of event is unknown).Subsequently, the charger encountered difficulty locating the ipg.In addition, the patient programmer was unable to communicate with the ipg and displayed a communication error message.Troubleshooting revealed the ipg was inoperable.Surgical intervention may be undertaken as the next course of action.

Event Description

Follow-up identified the ipg was explanted and replaced with a new model.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 road; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston road; plano TX 75024
• MDR Report Key: 5348690
• MDR Text Key: 35198336
• Report Number: 1627487-2016-00029
• 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: 04/08/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2011
• Device Model Number: 3788
• Device Lot Number: 2867459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/14/2016; 04/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other