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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 Discomfort (2330)
Event Date 03/27/2020
Event Type  malfunction  
Manufacturer Narrative
The charger was included in a field correction. Date of event is estimated. The investigation for capa (b)(4) associated with heating while charging (pocket heating) concluded that the charger was capable of transferring energy to the ipg at a rate that would cause heating of the ipg and/or charging wand of sufficient elevated temperature to cause pain and burns. The heating while charging was determined to be exacerbated by off-axis charging of shallow implanted ipgs and that all chargers were capable of elevated heating.
 
Event Description
Related manufacturer reference number: 1627487-2020-03556. It was reported the patient experienced pocket heating while charging the ipg. As a result, the ipg was explanted. The date of explant is unknown. The system was also explanted due to ineffective stimulation as documented in related manufacturer reference numbers 1627487-2020-03665 and 1627487-2020-03666.
 
Manufacturer Narrative
Added the checkmark that was inadvertently left off the initial report. During processing of this complaint, patient weight and complete event information were not requested due to patient not consenting to further contact. 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.
 
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Brand NameEON MINI CHARGING SYSTEM
Type of DeviceCHARGING 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 Key9975561
MDR Text Key188139530
Report Number1627487-2020-03557
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734402620
UDI-Public05414734402620
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
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2010
Device Model Number3721
Device Catalogue Number3721
Device Lot Number2884241
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 Received04/21/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/28/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/07/26/2012/001-C

Patient Treatment Data
Date Received: 04/17/2020 Patient Sequence Number: 1
Treatment
SCS IPG
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