MAUDE Adverse Event Report: ST. JUD MEDICAL - NEUROMODULATION EON MINI; SCS IPG

Model Number 3788

Device Problems Failure to Charge (1085); Failure to Conduct (1114); Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

The patient reports her ipg is unable to communicate with external devices.The patient states she last recharged her ipg approximately one month ago and approximately last received stimulation on (b)(6), 2014.The manufacturer has not been informed of 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.

• Brand Name: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUD MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4180507
• MDR Text Key: 5155231
• Report Number: 1627487-2014-26850
• 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
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Model Number: 3788
• Device Lot Number: 3702818
• Other Device ID Number: 05414734402651
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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: IMPLANT DATE:; IMPLANT DATE:; SCS LEAD, MODEL: 3183; SCS LEAD, MODEL: 3286
• Patient Age: 49 YR