EON RECHARGEABLE IPG, 16-CHANNEL 3716

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for EON RECHARGEABLE IPG, 16-CHANNEL 3716 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[186091949] Date of event is estimated. The results/method and conclusion codes along with investigation results will be provided in the final report. During processing of this complaint, attempts were made to obtain complete patient information.
Patient Sequence No: 1, Text Type: N, H10


[186091950] It was reported the patient was experiencing pain at the ipg site. As a result, the patient underwent surgical intervention during which the ipg was explanted and replaced to a different location.
Patient Sequence No: 1, Text Type: D, B5


[188595845] Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1627487-2020-03479
MDR Report Key9908944
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-12
Date Mfgr Received2020-03-12
Device Manufacturer Date2008-07-28
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANDREA DEITZ
Manufacturer Street6901 PRESTON ROAD
Manufacturer CityPLANO TX 75024
Manufacturer CountryUS
Manufacturer Postal75024
Manufacturer Phone9723098000
Manufacturer G1ST. JUDE MEDICAL - NEUROMODULATION
Manufacturer Street6901 PRESTON RD
Manufacturer CityPLANO TX 75024
Manufacturer CountryUS
Manufacturer Postal Code75024
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEON RECHARGEABLE IPG, 16-CHANNEL
Generic NameSCS IPG
Product CodeLGW
Date Received2020-03-31
Model Number3716
Catalog Number3716
Lot Number119749
Device Expiration Date2010-07-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL - NEUROMODULATION
Manufacturer Address6901 PRESTON RD PLANO TX 75024 US 75024


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-31

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.