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

Model Number 3788

Device Problems Pocket Stimulation (1463); Low impedance (2285)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Increased (2272); Inadequate Pain Relief (2388)

Event Date 06/19/2014

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Device 1 of 2.Ref mfr report: 1627487-2014-21479.The pt received two leads with the same lot number.It was reported the pt (b)(6) experiences pain at the lead site which is alleviated without stimulation identified reprogramming was unsuccessful as the pain did not completely resolve.The pt also experiences unpleasant stimulation at the ipg site.Diagnostics indicated low lead impedance on several contacts.The pt was given several programs to reduce the pain/sharpness sensation.X-rays have been ordered as the next course of action.

• Brand Name: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 3954875
• MDR Text Key: 21156048
• Report Number: 1627487-2014-21478
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/19/2014

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: 06/01/2014
• Device Model Number: 3788
• Device Lot Number: 3733687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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 DATE:; SCS EXTENSION: MODEL 3383 (2)
• Patient Outcome(s): Other
• Patient Age: 29 YR