NURO 3533

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-20 for NURO 3533 manufactured by Medtronic Neuromodulation.

Event Text Entries

[73326192]
Patient Sequence No: 1, Text Type: N, H10


[73326193] The patient reported via manufacture representative that their therapy was on hold due to being in the hospital with a congested heart failure, uti, pneumonia and a sinus infection. No environmental/external/patient factors led or contributed to the issue. The patient was reported to be alive with no injury. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5


[100185538] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007566237-2017-01513
MDR Report Key6508326
Report SourceCONSUMER
Date Received2017-04-20
Date of Report2017-04-20
Date Mfgr Received2017-03-28
Date Added to Maude2017-04-20
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 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 NameNURO
Generic NameSTIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
Product CodeNAM
Date Received2017-04-20
Model Number3533
Catalog Number3533
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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
101. Hospitalization; 2. Other 2017-04-20

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