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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL EON PATIENT PROGRAMMER
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ST. JUDE MEDICAL EON PATIENT PROGRAMMER Back to Search Results
Model Number 3851
Device Problems Sticking (1597); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem Inadequate Pain Relief (2388)
Event Date 03/03/2014
Event Type  malfunction  
Event Description
The patient reported, she received an error code 1202 (button error message) on the programmer and was unable to increase stimulation.The patient was instructed to use a pen to pull the '+' button up which resolved the issue.
 
Manufacturer Narrative
Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevance of the patient's history to the event reported.Sjm defers tot he patient's physician regarding medical history.
 
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Brand Name
EON PATIENT PROGRAMMER
Type of Device
PATIENT PROGRAMMER
Manufacturer (Section D)
ST. JUDE MEDICAL
neuromodulation
plano TX
Manufacturer Contact
palka sharma
6901 preston rd.
plano, TX 75024
9725264828
MDR Report Key3807203
MDR Text Key4388454
Report Number1627487-2014-21177
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
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2010
Device Model Number3851
Device Lot Number176438
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/03/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2008
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 IPG: MODEL 3788; SCS EXTENSION: MODEL 3386(2); IMPLANT DATE:; SCS LEAD: MODEL 3186(2); IMPLANT DATE:
Patient Age53 YR
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