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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION EON MINI; SCS IPG Back to Search Results
Model Number 3788
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 07/28/2014
Event Type  Injury  
Event Description
It was reported surgical intervention is pending to remove the pt's ipg.No add'l info is available at this time.
 
Manufacturer Narrative
Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.
 
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Brand Name
EON MINI
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
tanja hoffman
6901 preston rd.
plano, TX 75024
9723098520
MDR Report Key4044203
MDR Text Key4859804
Report Number1627487-2014-26656
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
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/01/2014
Device Model Number3788
Device Lot Number3878689
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2012
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
IMPLANT DATE:; SCS LEAD: MODEL 3219
Patient Outcome(s) Other;
Patient Age68 YR
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