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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI
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ST. JUDE MEDICAL - NEUROMODULATION EON MINI Back to Search Results
Model Number 3788
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Inoperable (1663); Delayed Charge Time (2586)
Patient Problem Shock (2072)
Event Date 12/05/2013
Event Type  Injury  
Event Description
Device 3 of 3.Ref mfr.Reports: 1627487-2012-03084 and 1627487-2012-03085.
 
Manufacturer Narrative
This ipg serial number was included in a field advisory.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
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
rachel blackwell
6901 preston rd.
plano, TX 75024
9725264637
MDR Report Key3674154
MDR Text Key18298883
Report Number1627487-2014-03009
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
Remedial Action Recall
Type of Report Initial
Report Date 12/05/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2013
Device Model Number3788
Device Lot Number3315469
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/05/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487-07262012-002-R
Patient Sequence Number1
Treatment
SCS ANCHOR, MODEL 1192 (2); IMPLANT DATE:
Patient Outcome(s) Other;
Patient Age45 YR
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