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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 Problems Detachment Of Device Component (1104); Disconnection (1171)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/14/2013
Event Type  Injury  
Event Description
Device 3 of 3.Reference mfr report: 1627487-2013-24352 and 24353.
 
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 MINI
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer Contact
arnie ochoa
6901 preston rd.
plano, TX 75024
9723098090
MDR Report Key3697177
MDR Text Key21877347
Report Number1627487-2014-02147
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 02/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2015
Device Model Number3788
Device Lot Number3956055
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
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 ANCHOR, MODEL 1192 (X2); IMPLANT DATE:
Patient Outcome(s) Other;
Patient Age58 YR
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