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U.S. Department of Health and Human Services

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

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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 Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient experienced inconvenience due to the ipg turning off/ on unintendedly. Surgical intervention may be taken 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.
 
Event Description
Additional information received identified the ipg was explanted and replaced with another model which resolved 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.
 
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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 Key5799237
MDR Text Key49737828
Report Number1627487-2016-03667
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 company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2011
Device Model Number3788
Device Lot Number2897074
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2010
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: 07/15/2016 Patient Sequence Number: 1
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