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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 Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Inoperable (1663)
Patient Problem Pain (1994)
Event Date 11/01/2014
Event Type  Injury  
Event Description
Follow up information identified the ipg was inoperable.It is unknown if errors were displayed.In addition, it is unknwn when stimulation was lost and the last time the ipg was recharged.
 
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.
 
Manufacturer Narrative
Results: the complaint for ¿no communication¿ was confirmed.As returned, the ipg would not communicate due to a depleted battery.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.The complaint for ¿discomfort¿ at the ipg site was not confirmed.The ipg was programmed with aggressive settings and monitored for an hour without any signal deviation from the initial outputs values observed.No anomalous outputs were observed on the programmed channels or the can.The magnet feature functioned as intended.After the battery was recovered, the device displayed normal device characteristics.The charging history of the ipg is unknown.The reason for the depleted battery was not ascertained.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
The patient reports that he is experiencing electrical pain at the ipg site.The pain is the same with stimulation turned off and the pain is not worse with the stimulation turned on.The pain started after he bent down one day.Despite the ipg being inoperable the patient continued to experience the shocking and pain at the ipg site, hence the patient underwent surgical intervention to remove the entire scs system.
 
Manufacturer Narrative
Correction number: 1627487-05242011-002-r.This ipg serial number was included in field advisories 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 preston road
plano TX 75024
MDR Report Key4329906
MDR Text Key5119795
Report Number1627487-2014-22024
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 Consumer,Company Representative
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 03/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/28/2012
Device Model Number3788
Device Lot Number3208617
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1627487-12192011-003-R
Patient Sequence Number1
Treatment
MODEL 3288, SCS LEAD
Patient Outcome(s) Other;
Patient Age33 YR
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