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 2018-09-14 for NURO 3533 manufactured by Medtronic Neuromodulation.

Event Text Entries

[120314051] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[120314052] Information was received from a consumer (con) regarding a patient who was using an external neurostimulator (ens) for urge incontinence. It was reported that the patient had their first treatment on the day of the report and the used a catheter and a cystic camera. The patient felt sore after the procedure, but stated that was expected. No device issues or further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007566237-2018-02750
MDR Report Key7877939
Report SourceCONSUMER
Date Received2018-09-14
Date of Report2018-09-14
Date of Event2018-08-20
Date Mfgr Received2018-08-20
Date Added to Maude2018-09-14
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 NameNURO
Generic NameSTIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
Product CodeNAM
Date Received2018-09-14
Model Number3533
Catalog Number3533
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
101. Required No Informationntervention 2018-09-14

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