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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC PASSIVE BIOPSY NEEDLE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733068
Device Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
Event Type  malfunction  
Manufacturer Narrative
Patient age not available from the site. Patient weight not available from the site. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used in a cranial biopsy procedure. It was reported that the biopsy needle was not being seen by the camera. Trajectory was locked and all appropriate steps were followed. The biopsy needle instrument came up on the navigation screen but could not be seen and was red. The patient reference frame and other probes were tracked with no issues. The biopsy steps were replicated post-surgery and the biopsy needle still did not show up. The spheres were clean as well as inspected for any damage. The spheres looked normal. The issue was not resolved. The biopsy was completed without navigating the biopsy needle. There was less than an hour delay to the case. No impact on patient outcome.
 
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Brand NamePASSIVE BIOPSY NEEDLE
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 Key13010669
MDR Text Key284011472
Report Number1723170-2021-02891
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K971247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733068
Device Catalogue Number9733068
Device Lot Number066521521
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/03/2021
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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