• 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 Burning Sensation (2146)
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: 3721, scs charging system, therapy date: unknown.
 
Event Description
Device 1 of 2. Reference mfr. Report#: 1627487-2019-12011. 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 1 of 2: reference mfr. Report#: 1627487-2019-12011.
 
Event Description
Device 1 of 2 reference mfr. Report#: 1627487-2019-12011.
 
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 Key9246824
MDR Text Key164038938
Report Number1627487-2019-12010
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 Date01/28/2015
Device Model Number3788
Device Lot Number3894365
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 Manufactured01/02/2013
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
-
-