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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI CHARGING SYSTEM

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ST. JUDE MEDICAL - NEUROMODULATION EON MINI CHARGING SYSTEM Back to Search Results
Model Number 3721
Device Problem Temperature Problem (3022)
Patient Problem Burning Sensation (2146)
Event Date 04/30/2020
Event Type  Injury  
Manufacturer Narrative
Date of the event is estimated. The results of the investigation are inconclusive since the device was not returned for analysis.   based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
Related manufacturer reference number: 1627487-2020-04651. It was reported the patient experienced pocket heating while charging their ipg. Surgical intervention took place where the scs system was explanted at an unknown date to address the issue.
 
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Brand NameEON MINI CHARGING SYSTEM
Type of DeviceEON MINI CHARGING SYSTEM
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10060919
MDR Text Key191100992
Report Number1627487-2020-04650
Device Sequence Number1
Product Code LGW
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,health professional
Reporter Occupation
Type of Report Initial
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2012
Device Model Number3721
Device Catalogue Number3721
Device Lot Number3562170
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/15/2020 Patient Sequence Number: 1
Treatment
MODEL # 3788 - IPG
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