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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 Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
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 device being used during a cranial biopsy procedure. It was reported that the vertek biopsy precision aiming device would not lock properly. The locking mechanism responsible for gross movements would not lock. A second vertek biopsy set was used to complete the procedure. The procedure was delayed by 5 minutes. There was no impact on patient outcome.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12274126
MDR Text Key264962809
Report Number1723170-2021-01993
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2021
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 Number150303
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 Received07/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/03/2015
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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