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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. LEFT THORACIC PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. LEFT THORACIC PROBE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/30/2020
Event Type  malfunction  
Event Description
Navigated medtronic gearshift broke off in patient vertebrae during surgery. After multiple failed attempts to remove the embedded piece of instrument, surgeon consulted medtronic concerning the safety of the materials in the remaining piece. After careful review of the risks/benefits, surgeon decided to leave the piece in the patient. This instrument is manufactured by medtronic, and is instrument kit #9735206 left thoracic probe. The serial numbers are (b)(4) and (b)(4). Fda safety report id# (b)(4).
 
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Brand NameLEFT THORACIC PROBE
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC.
MDR Report Key10319612
MDR Text Key200654533
Report NumberMW5095686
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/21/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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