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

Model Number 3788

Device Problem Charging Problem (2892)

Patient Problems Inadequate Pain Relief (2388); Weight Changes (2607)

Event Date 12/31/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 reported stimulatiion was lost approximately 2 weeks ago and the charger cannot locate the ipg.Reportedly, a replacement charger was sent to no avail.The patient programmer displays an error message.In addition, space was added between the paddle and ipg due to the patient previously losing 50lbs.The patient further states the ipg started to move around in the pocket.As a result, surgical intervention was decided as the next course of action.Follow-up idenified the ipg was explanted and replaced during surgery on (b)(6) 2016.

Event Description

Follow-up identified 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: 5472348
• MDR Text Key: 39415284
• Report Number: 1627487-2016-01016
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/04/2016

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: 01/28/2016
• Device Model Number: 3788
• Device Lot Number: 4444731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/14/2016; 03/18/2016; 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR