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

Model Number 3788

Device Problems Telemetry Discrepancy (1629); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/19/2014

Event Type  Injury  

Event Description

It was reported the pt (b)(6) was no longer able to establish communication between the ipg and external devices (patient programmer and charging system).In addition, the pt reported he lost stimulation.An add'l pt programmer and charging system were tried to no avail.The patient programmer displayed communication and telemetry error messages.Surgical intervention will be undertaken at a later date to resolve the reported issue.

Manufacturer Narrative

This ipg serial number was included in a field advisory.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; 6901 preston rd.; plano TX 75024
• Manufacturer (Section G): ST JUDE MEDICAL NEUROMODULATION; 6901 preston rd.; plano TX 75024
• Manufacturer Contact: karin bechler ; 6901 preston rd.; plano, TX 75024 ; 9723092511
• MDR Report Key: 3709116
• MDR Text Key: 4247882
• Report Number: 1627487-2014-10076
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/25/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: 3788
• Device Lot Number: 3439215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other