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

Model Number 3688

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Weight Changes (2607)

Event Date 09/21/2015

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.Udi(di): (b)(4).

Event Description

It was reported the patient has lost over 50 pounds.Since then the ipg is protruding making the pocket site uncomfortable, which is intensified when stimulation is on.The patient is pending a consultation with the physician.

Event Description

The patient's ipg was revised where the ipg was buried deeper.The patient's system was reprogrammed and the patient's issue was resolved.

• Brand Name: EON C 16-CHANNEL IPG
• 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: 5329138
• MDR Text Key: 34439838
• Report Number: 1627487-2015-13907
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 3688
• Device Lot Number: 4103422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2013
• 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
• Treatment: MODEL 3341, SCS EXTENSION
• Patient Outcome(s): Other
• Patient Age: 48 YR