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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Weight Changes (2607)
Event Date 06/30/2015
Event Type  Injury  
Event Description
It was reported the patient is experiencing pain at the ipg site.In addition, the patient reports she has lost weight.Follow up information identified the patient underwent surgical intervention where the entire scs system was explanted and the issue is now resolved.
 
Manufacturer Narrative
(b)(4).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.
 
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.
 
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 Name
EON MINI IPG, 16-CHANNEL RECHARGEABLE
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL NEUROMODULATION DIVISION
6901 presto road
plano TX 75024
MDR Report Key4931961
MDR Text Key6050367
Report Number1627487-2015-26324
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 Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/28/2014
Device Model Number3788
Device Lot Number3603851
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/30/2012
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 3341, SCS EXTENSION; MODEL 3166 (2), SCS LEAD; MODEL 3286, SCS LEAD
Patient Outcome(s) Other;
Patient Age60 YR
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