ENTERRA 37800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-29 for ENTERRA 37800 manufactured by Medtronic Neuromodulation.

Event Text Entries

[176852929] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[176852930] Information was received from a healthcare professional (hcp) regarding a patient who was being implanted with a neurostimulator for gastric stimulation. It was reported that the hcp was in the operating room (or) implanting a device and was seeing impedances over 800. No symptoms or further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007566237-2020-00155
MDR Report Key9643006
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-29
Date of Report2020-01-29
Date of Event2020-01-20
Date Mfgr Received2020-01-20
Date Added to Maude2020-01-29
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 ContactLISA WOODWARD CLARK
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635263920
Manufacturer G1MEDTRONIC NEUROMODULATION
Manufacturer Street800 53RD AVE NE
Manufacturer CityMINNEAPOLIS MN 554211200
Manufacturer CountryUS
Manufacturer Postal Code554211200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENTERRA
Generic NameINTESTINAL STIMULATOR
Product CodeLNQ
Date Received2020-01-29
Model Number37800
Catalog Number37800
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NEUROMODULATION
Manufacturer Address800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-29

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