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

Model Number 3788

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/01/2014

Event Type  Injury  

Event Description

It was reported approximately a few weeks ago the patient's ((b)(6)) ipg was turning off a few times per day.Additionally, it was reported the patient attempted to communicate with the ipg but was unsuccessful.As a result, surgical intervention was undertaken to explant and replace the ipg which resolved the issue.

Manufacturer Narrative

Field correction: 1627487-12192011-003-r, 1627487-07262012-002-r.This ipg serial number is 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: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 4023209
• MDR Text Key: 4846149
• Report Number: 1627487-2014-25557
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2012
• Device Model Number: 3788
• Device Lot Number: 3088835
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR