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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL EON MINI SPINAL CORD STIMULATOR "STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF"

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ST. JUDE MEDICAL EON MINI SPINAL CORD STIMULATOR "STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF" Back to Search Results
Model Number 3788
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Injury (2348)
Event Date 10/11/2018
Event Type  malfunction  
Event Description
Patient reports that the device caused harm while implanted.
 
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Brand NameEON MINI SPINAL CORD STIMULATOR
Type of Device"STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF"
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key7999500
MDR Text Key125277537
Report NumberMW5080764
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3788
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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