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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SMALL PASSIVE REFERENCE FRAME INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC SMALL PASSIVE REFERENCE FRAME INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 961-337
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 03/13/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that while setting up for a case, the frame was going in and out of view. The geometry error was sitting between 0. 4 and 0. 5. Another frame was used for the upcoming case. There was no patient involved when this issue was discovered.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information: the representative went to the site but was unable to replicate the issue.
 
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Brand NameSMALL PASSIVE REFERENCE FRAME
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9921034
MDR Text Key186334028
Report Number1723170-2020-01150
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number961-337
Device Catalogue Number961-337
Device Lot Number180125
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/25/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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