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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC EQUIPMENT RACK I7 INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC EQUIPMENT RACK I7 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9734060
Device Problem Imprecision (1307)
Patient Problems Intracranial Hemorrhage (1891); Brain Injury (2219)
Event Date 07/09/2020
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 9735585, version: 3. 1. 1. A medtronic representative went to the site to test the equipment. The system performed as intended and passed a system checkout. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for an electrode and probe placement procedure. It was reported that there was a navigation inaccuracy. The site was using a precision aiming device (pad) and had done a biopsy earlier in the procedure. No inaccuracies were noted during the biopsy. During the probe placement procedure, three bolts were placed using navigation. Catheter length measurement was performed with the precision aiming device (pad) probe using the navigation system. It was unclear if the surgeon used distance to divot or cut window length value for measurement. The first catheter was placed accurately, and the second and third lengths were off by 50 millimeters. When the surgeon and resident placed the second catheter, they felt resistance and stopped, indicating potential piercing of the brain stem. The catheters (fibers) and bolts were removed and the electrode/probe placement portion of the procedure was aborted. No electrodes were placed. The surgery was aborted and the patient was taken to computed tomography (ct) and brought to the intensive care unit (icu) for careful monitoring and no other procedures were performed. There was a less than 1 hour delay. It was confirmed that the patient had a brain stem injury which resulted in intracranial hemorrhage. No additional procedures were scheduled or indicated at the time. The patient is now in stable condition and improving. After going over the case, it was suspected that the inaccuracy was in the fiber length. The surgeon used the pad probe on top of the bone anchor and then read the number off from there. It was believed that the surgeon read off the cut window depth and not the distance to target length.
 
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Brand NameEQUIPMENT RACK I7
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 Key10297803
MDR Text Key199651563
Report Number1723170-2020-01967
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734060
Device Catalogue Number9734060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/20/2020 Patient Sequence Number: 1
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