Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problems No Device Output (1435); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/07/2014
Event Type  Injury  
Event Description
Follow-up information indicated surgical intervention was undertaken and the patient's ipg was explanted and replaced.The patient reported effective stimulation coverage postoperative.
 
Manufacturer Narrative
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.
 
Event Description
The patient reported he is without stimulation and is unable to communicate with or charge his ipg.The patient had not charged his ipg for approximately 5-6 weeks.The patient's programmer displayed a communication error message.The sjm representative met with the patient and confirmed the issue.Surgical intervention may take place at a later date to address the issue.
 
Manufacturer Narrative
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EON MINI IPG, 16-CHANNEL RECHARGEABLE
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key4371028
MDR Text Key5492954
Report Number1627487-2014-15927
Device Sequence Number1
Product Code GZB
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 Other
Type of Report Initial,Followup
Report Date 02/02/2015
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 Date11/28/2013
Device Model Number3788
Device Lot Number3553124
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/02/2015
Initial Date FDA Received12/30/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MODEL 3228, SCS LEAD
Patient Outcome(s) Other;
Patient Age47 YR
-
-