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

Model Number 3788

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/10/2014

Event Type  Injury  

Event Description

Device 3 of 3.Reference mfr report 1627487-2014-23546, 1627487-2014-23547.

Manufacturer Narrative

Results: - the ipg, as received, as responsive and communicated with lab utilities.Visual inspection of the ipg header assembly revealed the lower septum had been cored and there was evidence of fluid intrusion inside the header assembly.Fluid intrusion into the header assembly can result in changes to the system impedances and stimulation.This could have also contributed to the reported issue.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: jennifer shepard ; 6901 preston rd.; plano, TX 75024 ; 9725264657
• MDR Report Key: 4252729
• MDR Text Key: 4993237
• Report Number: 1627487-2014-23731
• 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: 10/10/2014

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: 07/01/2014
• Device Model Number: 3788
• Device Lot Number: 3757717
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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:; SCS ANCHOR: MODEL 1192
• Patient Outcome(s): Other
• Patient Age: 64 YR