• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Thrombosis/Thrombus (4440)
Event Date 03/01/2021
Event Type  Injury  
Event Description
Detchou, d. K. , glauser, g. , dimentberg, r. , schuster, j. M. , malhotra, n. R. Case series of ultrasonic navigated osteotomy for the treatment of spinal chordomas. World neurosurgery. 150: e347-e352 https://doi. Org/10. 1016/j. Wneu. 2021. 03. 001 - background: chordomas present challenges for en bloc surgical resection, which optimally reduces local recurrence and increases pa tient survival. Navigated ultrasonic osteotomy, also known as piezosurgery, provides a distinct advantage for achieving negative margins after en bloc resection. - methods: eight consecutive patients with chordomas (2 cervical, 3 lumbar, and 3 sacral) treated with navigated ultrasonic osteotomy to achieve en bloc resection were identified from our institutional spine tumor database (2016e2019) and retrospectively reviewed. - results: en bloc resection, with negative margins, was achieved in all cases. Two patients (25%) were women, and mean age at surgery was 44 11 years. Median estimated blood loss was 1000 ml (interquartile range: 263e1500 ml). Median length of hospital stay was 10 days (interquartile range: 3e19. 5 days). Two patients required a revision procedure. Two patients had complications requiring readmission within the 30-day postoperative window. Mean duration of follow-up for the cohort was 900 554 days. - conclusions: navigated ultrasonic osteotomy is an effective surgical technique to achieve en bloc resection of chordomas with negative margins and disease-free survival. To date, this represents the first reported cohort of patients undergoing the procedure as described here. Future studies should include larger sample sizes for more robust clinical outcome data to further elucidate the benefits of piezosurgery for obtaining en bloc chordoma resection. Reported events: two patients (25%) required a revision procedure. One of the revision procedures was complicated by intraoperative hemorrhage (6500 ml). Two patients had complications requiring readmission within the 30- day postoperative window. One patient had a surgical site infection, and the other patient had a deep vein thrombosis.
 
Manufacturer Narrative
Patient age is the mean value of patients in the study. Patient gender is the majority value of patients in the study. Patient weight not available from the site. Event date is the accepted date of the literature article. D4) device lot number, or serial number, unavailable. 510(k) is dependent upon the device model number and is therefore, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacture date is dependent on the device lot/serial number, therefore is unavailable. Please look at regulatory report number 3004785967-2021-01318 for the imaging system mentioned in the article. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEDTRONIC NAVIGATION
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 Key12865035
MDR Text Key285946057
Report Number1723170-2021-02749
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 Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK_NAV_SYS
Device Catalogue NumberUNK_NAV_SYS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? No
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: 11/23/2021 Patient Sequence Number: 1
-
-