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

Model Number 3788

Device Problems Failure to Charge (1085); Low Battery (2584); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2014

Event Type  malfunction  

Event Description

It was reported the ipg was no longer able to communicate with the charging system.The programmer displays low battery warning and is able to communicate with the ipg.A replacement charging system did not resolve the issue.The system is to consult with the physician regarding the next course of action to address the issue.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4094838
• MDR Text Key: 4761771
• Report Number: 1627487-2014-26727
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: 3788
• Device Lot Number: 3968828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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: SCS LEAD: MODEL 3228; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 46 YR