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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

The 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. The manufacturer defers to the patient's physician regarding medical history.

 
Event Description

It was reported the patient experienced the ipg turning itself off and back on for the last ten months. Troubleshooting did not resolve the issue, therefore the physician explanted and replaced the patient¿s ipg.

 
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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 Key7570164
MDR Text Key110108160
Report Number1627487-2018-05416
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2015
Device MODEL Number3788
Device LOT Number4110683
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/30/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/17/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/10/2013
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: 06/05/2018 Patient Sequence Number: 1
Treatment
MODEL 3163, SCS LEAD; MODEL 3245, SCS LEAD
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