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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 06/04/2020
Event Type  Death  
Manufacturer Narrative
This value is the average age of the patients reported in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. No patient weight was available in the article. Patient death date was not available in the article. Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature. The unique identifier was not available at the time of reporting. No parts have been received by the manufacturer for evaluation. The manufacture date was not available at the time of reporting. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Li, c. , zhu, h. , zong, x. , wang, x. , gui, s. , zhao, p. , liu, c. , bai, j. , cao, l. And zhang, y. Application of endoscopic endonasal approach in skull base surgeries: summary of 1886 cases in a single center for 10 consecutive years. Chinese neurosurgical journal. 2020 6:21 1-8. Doi: 10. 1186/s41016-020-00199-w background: endonasal endoscopic skull base surgery has undergone rapid technological developments and is now widely performed, but its strengths and weaknesses deserve further investigation and deliberation. This study was performed to investigate the surgical indications, complications, and technical advantages and disadvantages of endonasalendoscopic skull base surgery. Methods: the clinical data of 1886 endoscopic endonasal skull base surgeries performed in our ward at beijing tiantan hospital from june 2006 to june 2016 were retrospectively analyzed. Results: one thousand ninety-three (73. 4%, 1490) pituitary adenomas, 54 (24. 9%, 217) chordomas, 28 (80. 0%, 35) craniopharyngiomas, and 15 (83. 3%, 18) meningiomas underwent total resection. Two patients died postoperatively, both having pituitary adenomas. Other postoperative complications included olfactory disorders (n
=
226, 11. 9%), postoperative cerebrospinal fluid leakage (n
=
78, 4. 1%), h ypopituitarism (n
=
74, 3. 9%), diabetes insipidus (n
=
64, 3. 4%), intracranial infection (n
=
36, 1. 9%), epistaxis (n
=
24, 1. 3%), vascular injury (n
=
8, 0. 4%), optic nerve injury (n
=
8, 0. 4%), and oculomotor movement impairment (n
=
4, 0. 2%). In total, 1517 (80. 4%) patients were followed up for 6 to 126 months (average, 42. 5 months) postoperatively. A total of 196 (13. 2%) pituitary adenomas and 13 (37. 1%) craniopharyngiomas recurred but no meningiomas recurred. Chordomas recurred in 97 (44. 7%) patients, in whom 5-year survival rate was 65%. Conclusion: endoscopic surgery is an innovative surgical technique and the first choice for most midline extradural lesions such as chordomas, and an excellent choice for pituitary adenomas. It probably will be a good technique for many kinds of craniopharyngiomas and a common technique for most of skull base meningiomas, so the surgical indications of these cases should be chosen carefully to make good use of its respective advantages. Reported events: two patients died postoperatively, both were invasive pituitary adenomas. One died of intraoperative carotid artery rupture, and the other died of postoperative intracranial hematoma caused by residual tumor. Olfactory disorders (n
=
226, 11. 9%) postoperative cerebrospinal fluid leakage (n
=
78, 4. 1%) hypopituitarism (n
=
74, 3. 9%) diabetes insipidus (n
=
64, 3. 4%), intracranial infection (n
=
36, 1. 9%) epistaxis (n
=
24, 1. 3%), vascular injury (n
=
8, 0. 4%), optic nerve injury (n
=
8, 0. 4%) oculomotor movement impairment (n
=
4, 0. 2%) 196 (13. 2%) with pituitary adenomas and 13 (37. 1%) with craniopharyngiomas developed recurrence recurrence of chordomas occurred in 97 (44. 7%) patients.
 
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Brand NameMEDTRONIC NAVIGATION
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 Key11048018
MDR Text Key222789020
Report Number1723170-2020-03360
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
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: 12/21/2020 Patient Sequence Number: 1
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