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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL - NEUROMODULATION EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG Back to Search Results
Model Number 3716
Device Problem Device Stops Intermittently (1599)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Injury  
Manufacturer Narrative
Manufacturer 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. Manufacturer defers to the patient's physician regarding medical history.
 
Event Description
Device 2 of 2. Reference mfr. Report# 1627487-2017-07913. Additional information received (b)(6) identified the patient underwent surgical intervention on (b)(6) 2018 wherein the lead was determined to be normal. However the ipg was unable to provide stimulation. As a result the ipg was explanted and replaced which resolved the issue. Effective stimulation was restored postoperatively. Ipg is added as device 2. Implant date 2011 ( exact implant date unknown).
 
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Brand NameEON RECHARGEABLE IPG, 16-CHANNEL
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 Key7282755
MDR Text Key100444921
Report Number1627487-2018-01536
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2014
Device Model Number3716
Device Catalogue Number3716
Device Lot Number3776166
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2012
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: 02/20/2018 Patient Sequence Number: 1
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