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

Model Number 3788

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/17/2013

Event Type  Injury  

Event Description

Device 2 of 2.Ref mfr.Report#: 1627487-2013-25005.

Manufacturer Narrative

Results: the complaint of "ineffective stimulation" was confirmed.Visual inspection of the returned ipg did reveal cored septums and discoloration in the bottom of the header.Fluid intrusion in the septum would cause degraded outputs condition.The cored septa likely caused a leakage path to the septa and this could create ineffective stimulation.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: benjyna obasuji ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 3697142
• MDR Text Key: 4245408
• Report Number: 1627487-2014-25149
• 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: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2014
• Device Model Number: 3788
• Device Lot Number: 3804043
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/06/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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: SCS ANCHORS, MODEL: 1192 (X2); IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 55 YR