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

Model Number 3788

Device Problems Telemetry Discrepancy (1629); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/16/2014

Event Type  Injury  

Event Description

It was reported the pt has been unable to recharge the ipg and as a result, stimulation was lost approximately 2 weeks ago.Reportedly, the charging system successfully connects to the ipg for a short period of time, however an leds indicate error occurs.Troubleshooting with a second charging system was attempted to no avail.Surgical intervention may be the next course of action to address the issue.

Manufacturer Narrative

This ipg serial number was included in a field advisory.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.

• Brand Name: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 3979977
• MDR Text Key: 21448462
• Report Number: 1627487-2014-01484
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: 3788
• Device Lot Number: 3450402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Treatment: IMPLANTED:; SCS LEAD: MODEL 3146; SCS LEAD: MODEL 3286; SCS ANCHOR: MODEL 1192; IMPLANTED:; IMPLANTED:
• Patient Outcome(s): Other
• Patient Age: 55 YR