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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PASSIVE PLANAR BLUNT PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PASSIVE PLANAR BLUNT PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 960-556
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device lot number and serial number, unavailable at the time of filing. No parts have been returned to the manufacturer for analysis. Device manufacture date is not available at time of filing.
 
Event Description
Medtronic received information regarding a navigation device being used outside a procedure. It was reported that the passive planar probe was bent. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Correction: udi inadvertently filed. The udi is not available at this time.
 
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Brand NamePASSIVE PLANAR BLUNT PROBE
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
jack edell
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7588768
MDR Text Key110710389
Report Number1723170-2018-02678
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number960-556
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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