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

Model Number 3788

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Seizures (2063); Inadequate Pain Relief (2388)

Event Date 04/19/2014

Event Type  Injury  

Event Description

Device 2 of 2 - reference mfr.Report:1627487-2014-21534; the patient received two scs leads with the same lot number.It was reported the patient experienced a seizure which resulted in a fall directly on the ipg site.The incident resulted in ineffective stimulation and per the patient, a change in the original pain pattern.The physician proceeded with a system in order to have an mri to evaluate the patient's pain pattern.

Manufacturer Narrative

This ipg serial number was included in a field advisory.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: palka sharma ; 6901 preston road; plano, TX 75024 ; 9725264823
• MDR Report Key: 4059240
• MDR Text Key: 4906848
• Report Number: 1627487-2014-21537
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2013
• Device Model Number: 3788
• Device Lot Number: 3290662
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2011
• 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
• Treatment: IMPLANT DATE:; SCS ANCHOR: MODEL 1192(2)
• Patient Outcome(s): Other
• Patient Age: 38 YR