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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON PATIENT PROGRAMMER
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ST. JUDE MEDICAL - NEUROMODULATION EON PATIENT PROGRAMMER Back to Search Results
Model Number 3851
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The patient reported he received an error message on his patient programmer indicating the (-) button was stuck.Subsequently, a replacement programmer was sent to the patient and switched out with the original programmer as troubleshooting with the original device did not resolve the issue.The issue was resolved with the replacement programmer.
 
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 PATIENT PROGRAMMER
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
rachel blackwell
6901 preston rd.
plano, TX 75024
9725264637
MDR Report Key3785986
MDR Text Key4377386
Report Number1627487-2014-03020
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2009
Device Model Number3851
Device Lot Number96550
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/26/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received12/13/2013
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2007
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
SCS EXTENSION: MODEL 3343; SCS EXTENSION: MODEL 3341; IMPLANT DATE:; SCS LEAD: MODEL 3166(2); SCS IPG: MODEL 3716; IMPLANT DATE:; IMPLANT DATE:; IMPLANT DATE:
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