• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG Back to Search Results
Model Number 3788
Device Problem Device Stops Intermittently (1599)
Patient Problem Inadequate Pain Relief (2388)
Event Date 02/27/2017
Event Type  Injury  
Event Description
Device 1 of 2. Reference mfr report #1627487-2017-02772.
 
Manufacturer Narrative
Abbott 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.
 
Event Description
Device 1 of 2. Reference mfr report #1627487-2017-02772. It was reported the ipg turns on and off intermittently. An abbott representative interrogated the system and reprogrammed. However, the issue persisted. X-rays showed no anomalies. Surgical intervention may take place to address the issue.
 
Event Description
Device 1 of 2. Reference mfr report #1627487-2017-02772. Follow up information identified the patient's ipg was replaced with a new one which resolved the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEON MINI IPG, 16-CHANNEL RECHARGEABLE
Type of DeviceSCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key6587901
MDR Text Key102409173
Report Number1627487-2017-02717
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2015
Device Model Number3788
Device Lot Number4022209
Other Device ID Number05414734402651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/24/2017 Patient Sequence Number: 1
-
-