• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG Back to Search Results
Model Number 3788
Device Problem Temperature Problem (3022)
Patient Problem Discomfort (2330)
Event Date 03/27/2020
Event Type  Injury  
Manufacturer Narrative
This ipg 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: 1627487-2020-03557. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEON MINI IPG, 16-CHANNEL RECHARGEABLE
Type of DeviceSCS IPG
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 Key9975560
MDR Text Key188138210
Report Number1627487-2020-03556
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734402651
UDI-Public05414734402651
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 Date11/28/2011
Device Model Number3788
Device Catalogue Number3788
Device Lot Number2880148
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
CHARGING SYSTEM
-
-