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

Model Number 3788

Device Problem Pocket Stimulation (1463)

Patient Problem Discomfort (2330)

Event Date 10/03/2014

Event Type  Injury  

Event Description

It was reported the patient is experiencing a jolting sensation for 3-4 minutes at the ipg site when stimulation is initially turned on which eventually subsides.The patient will be following up with his physician in the future.

Manufacturer Narrative

Correction numbers: 1627487-07262012-002-r, 1627487-05242011-002-r.This ipg serial number was included in field advisories.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: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4235958
• MDR Text Key: 4973511
• Report Number: 1627487-2014-26884
• Device Sequence Number: 1
• Product Code: IPG
• 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: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2012
• Device Model Number: 3788
• Device Lot Number: 3058402
• Other Device ID Number: 05414724402651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-12192011-003-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR