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

Model Number 3788

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/19/2014

Event Type  Injury  

Event Description

Device 2 of 2: ref mfr report: 1627487-2014-02418.The pt received two scs leads for the same lot number.It was reported the pt is not receiving any stimulation therapy from his scs system.The pt stated his stimulation had been intermittent.A diagnostics of the pt's system revealed all the contacts are invalid for both leads.Additional info received on (b)(6) 2014 identified the pt's scs lead were explanted and replaced.It was observed the leads appeared fractured with fluid inside the casing.In addition, it was uncertain if any fluid intruded in the pt's ipg, therefore, the physician decided to replace the pt's ipg.

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 JUDE MEDICAL- NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3926149
• MDR Text Key: 4582988
• Report Number: 1627487-2014-02419
• 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: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: 3788
• Device Lot Number: 4271699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR