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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 Date 11/14/2016
Event Type  Injury  
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
It was reported the patient's ipg stops intermittently. The patient states after approximately 5 minutes of turning the scs system on, the device stops by itself. The patient then loses stimulation. An abbot representative met with the patient and confirmed the issue. In turn, the patient will undergo surgical intervention to address the issue.
 
Event Description
Follow-up information revealed the patient underwent surgical intervention wherein the ipg was explanted and replaced with a different model. Reportedly, effective therapy was regained post-operatively.
 
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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 Key6564808
MDR Text Key75087385
Report Number1627487-2017-02541
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
Report Date 06/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2013
Device Model Number3788
Device Lot Number3528815
Other Device ID Number05414734402651
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2011
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: 05/12/2017 Patient Sequence Number: 1
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