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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EON MINI CHARGING SYSTEM SCS CHARGER

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ABBOTT MEDICAL EON MINI CHARGING SYSTEM SCS CHARGER Back to Search Results
Model Number 3721
Device Problem Temperature Problem (3022)
Patient Problem Burning Sensation (2146)
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.
 
Event Description
Related mfr report: 1627487-2021-01120. It was reported the patient complained of heating during recharge of the scs system implantable pulse generator (ipg). The patient stated the charger antenna heated up not allowing it to be placed on the skin. The next course of action has not been determined.
 
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Brand NameEON MINI CHARGING SYSTEM
Type of DeviceSCS CHARGER
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key11304990
MDR Text Key231107018
Report Number1627487-2021-01121
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Model Number3721
Device Catalogue Number3721
Device Lot Number5298105
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 Received07/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2015
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: 02/09/2021 Patient Sequence Number: 1
Treatment
MODEL 3788, SCS IPG
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