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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL - NEUROMODULATION EON MINI CHARGING SYSTEM SCS CHARGING SYSTEM Back to Search Results
Model Number 3721
Device Problem Temperature Problem (3022)
Patient Problem Burning Sensation (2146)
Event Date 10/02/2019
Event Type  Injury  
Manufacturer Narrative
This device model is associated with a field correction. The event date is unknown. The results/method and conclusion codes along with the investigation results will be provided in the final report. Concomitant medical products and therapy dates: model: 3788, scs ipg, therapy date: unknown.
 
Event Description
Device 2 of 2. Reference mfr. Report#: 1627487-2019-12010. This report is related to a (b)(6) patient. It was reported the patient had been experiencing pocket heating while recharging their ipg. As a result, the patient's ipg was explanted and replaced. Surgical intervention addressed the patient's issue.
 
Event Description
Device 2 of 2: reference mfr. Report#: 1627487-2019-12010.
 
Event Description
Device 2 of 2 reference mfr. Report#: 1627487-2019-12010.
 
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Brand NameEON MINI CHARGING SYSTEM
Type of DeviceSCS 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 Key9246831
MDR Text Key164038936
Report Number1627487-2019-12011
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2014
Device Model Number3721
Device Catalogue Number3721
Device Lot Number4059003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487-07262012-001-C

Patient Treatment Data
Date Received: 10/28/2019 Patient Sequence Number: 1
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