S8 PREMIUM 9735665

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 2020-03-26 for S8 PREMIUM 9735665 manufactured by Medtronic Navigation, Inc.

Event Text Entries

[185077347] Patient information was unavailable from the site. Other relevant device(s) are: product id: 9 735740, version #: 1. 2. 0. The manufacturer representative went to the site to test the navigation system. The reported issue was not confirmed and no parts were replaced. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185077348] Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure. It was reported that the behavior was set to cross-hairs moving and the software was not responding to a cross-hairs moving state. The manufacture representative had the site record a video of the issue. There was less than an hour delay in the case. No impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01073
MDR Report Key9883678
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-18
Date Mfgr Received2020-03-18
Device Manufacturer Date2018-03-23
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1MEDTRONIC NAVIGATION, INC
Manufacturer Street826 COAL CREEK CIRCLE
Manufacturer CityLOUISVILLE CO 80027
Manufacturer CountryUS
Manufacturer Postal Code80027
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameS8 PREMIUM
Generic NameINSTRUMENT, STEREOTAXIC
Product CodeHAW
Date Received2020-03-26
Model Number9735665
Catalog Number9735665
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NAVIGATION, INC
Manufacturer Address826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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