MAUDE Adverse Event Report: EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

Device Problems Charging Problem (2892); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/05/2014

Event Type  Injury  

Event Description

It was reported the patient gained a lot of weight.In turn, the charger was unable to communicate with the ipg.As a result the ipg would not turn on.X-rays revealed the ipg had tilted.Surgical intervention took place to explant and replace the ipg with a different model.

Manufacturer Narrative

Correction numbers: 1627487-07262012-002-r, 1627487-12192011-003-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 IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• MDR Report Key: 4377484
• MDR Text Key: 5238455
• Report Number: 1627487-2014-24432
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/05/2014

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: 12/28/2011
• Device Model Number: 3788
• Device Lot Number: 2897072
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 01/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2009
• 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
• Treatment: MODEL:3244, SCS LEAD; MODEL:3383, SCS EXTENSION
• Patient Outcome(s): Other
• Patient Age: 59 YR