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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC BIOPSY GUIDE NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC BIOPSY GUIDE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 960-539
Device Problems Use of Device Problem (1670); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2022
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 there was a defective biopsy guide.   no patient was present when the issue was identified. Additional information received from a manufacturer representative indicated it was impossible to lock the biopsy guide. The reported issue was thought to be related to normal use.
 
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Brand NameBIOPSY GUIDE
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14001985
MDR Text Key288795070
Report Number1723170-2022-00481
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00763000055578
UDI-Public00763000055578
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K954276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2014
Device Model Number960-539
Device Catalogue Number960-539
Device Lot Number080202
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2009
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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