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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 Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2014
Event Type  Injury  
Event Description
Device 4 of 4.Ref mfr reports: 1627487-2014-00312, 00313, 00314.
 
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
melissa nkematu
6901 preston rd.
plano, TX 75024
9723092520
MDR Report Key3954876
MDR Text Key4558022
Report Number1627487-2014-01462
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2014
Device Model Number3788
Device Lot Number3772666
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/30/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/23/2014
Initial Date FDA Received07/16/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2012
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
SCS ANCHOR: MODEL 1192 (3); IMPLANT DATE:
Patient Outcome(s) Other;
Patient Age53 YR
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