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

Model Number 3716

Device Problems Charging Problem (2892); Unintended Movement (3026)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/30/2014

Event Type  Injury  

Event Description

It was reported the patient (united kingdom) is experiencing charging difficulties along with intermittent communication.X-rays were ordered to address the issue.Follow-up reveals an ipg migration.It was further reported the patient previously underwent surgical intervention (date unknown) since moving to (b)(6) whereas the ipg was repositioned from the buttock to the abdomen.A replacement charger was sent as the next course of action.

Event Description

Follow-up identified the issue still persists.X-rays confirmed the ipg is deeper and positioned at an angel.Surgical intervention may be undertaken as the next course of action.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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

Follow-up identified surgical intervention was undertaken, explanting and replacing the ipg.Effective therapy was restored postoperatively.The issue is resolved.

Manufacturer Narrative

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 RECHARGEABLE IPG, 16-CHANNEL
• Type of Device: SCS IPG
• Manufacturer (Section G): ST. JUDE MEDICAL NEURMODULATION; 6901 preston road; 6901 preston road; plano TX 75024
• MDR Report Key: 4357690
• MDR Text Key: 5199937
• Report Number: 1627487-2014-01819
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2015

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: 02/28/2009
• Device Model Number: 3716
• Device Lot Number: 67328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2015; 02/26/2015; 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2007
• 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