NURO 3533

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2017-11-13 for NURO 3533 manufactured by Medtronic Neuromodulation.

Event Text Entries

[91888884] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[91888885] The consumer reported that the patient had a urinary tract infection. It was noted that they were going in tomorrow to have the first urinalysis to check whether they still had one. The patient had completed 5 sessions. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[101041347] Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. Additional information indicated that the uti was not related to the device/therapy. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[101041348]
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007566237-2017-04805
MDR Report Key7026600
Report SourceCONSUMER,HEALTH PROFESSIONAL
Date Received2017-11-13
Date of Report2017-12-11
Date of Event2017-11-09
Date Mfgr Received2017-12-05
Date Added to Maude2017-11-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 NameNURO
Generic NameSTIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
Product CodeNAM
Date Received2017-11-13
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. Other 2017-11-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.