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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INST 960-539 GUIDE BIOPSY INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC INST 960-539 GUIDE BIOPSY INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 960-539
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 08/14/2020
Event Type  malfunction  
Manufacturer Narrative
Not available on the date of filing. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that there was an anomaly of fixation with a biopsy guide instrument. No patient.
 
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Brand NameINST 960-539 GUIDE BIOPSY
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10496103
MDR Text Key206160282
Report Number1723170-2020-02375
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K954276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number960-539
Device Catalogue Number960-539
Device Lot Number140505
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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