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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG

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ABBOTT MEDICAL EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG Back to Search Results
Model Number 3788
Device Problem Disconnection (1171)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/01/2018
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated. The results/method and conclusion codes along with the investigation results will be provided in the final report.

 
Event Description

Device 1 of 2; reference mfr. Report#: 1627487-2020-33245. It was reported the patient began to receive ineffective therapy after a car accident occurred. Allegedly, the patient's ipg and lead were found to have been disconnected from each other following the car accident. As a result, the patient decided to have their scs system explanted.

 
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Brand NameEON MINI IPG, 16-CHANNEL RECHARGEABLE
Type of DeviceSCS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10780959
MDR Text Key214506400
Report Number1627487-2020-33244
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2015
Device MODEL Number3788
Device Catalogue Number3788
Device LOT Number3917429
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 Received12/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/18/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 11/03/2020 Patient Sequence Number: 1
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