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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 Urinary Tract Infection (2120)
Event Date 01/05/2015
Event Type  Injury  
Manufacturer Narrative
Patient age: this value is the average age of the patients reported in the article as specific patients could not be identified. Patient sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Event date: please note that this date is based off of the date of online publication of the article. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Weiner, gregory m. , et al. ¿ommaya reservoir with ventricular catheter placement for chemotherapy with frameless and pinless electromagnetic surgical neuronavigation. ¿ clinical neurology and neurosurgery, vol. 130, 5 jan. 2015, pp. 61¿66. , doi:10. 1016/j. Clineuro. 2014. 12. 018. Summary: background: accuracy inommayareservoir catheter placement is critical to chemotherapy infusion. Most frameless image guidance is light emitting diode (led) based, requiring a direct line of communication between instrument and tracker, limiting freedom of instrument movement within the surgical field. Electromagnetic neuronavigation may overcome this challenge. Objective: to compare ommaya reservoir ventricular catheter placement using electromagnetic neuronavigation to led-based optical navigation, with emphasis on placement accuracy, operative time and complication rate. Methods: twenty-eight patients who underwent placement of ommaya reservoirs at our institution between 2010 and 2014 with either electromagnetic (12 patients) or optical neuronavigation (16 patients) were retrospectively reviewed. Results: half of the patients were male. Their mean age was 56 years (range 28¿87 years). Accuracy and precision in catheter tip placement at the target site (foramen of monro) were both higher (p
=
0. 038 and p
=
0. 043, respectively) with electromagnetic neuronavigation. Unintended placement of the distal catheter contralateral to the target site occurred more frequently with optical navigation, as did superior or inferior positioning by more than 5mm. Mean operative times were shorter (p
=
0. 027) with electromagnetic neuronavigation (43. 2 min) than with optical navigation (51. 0 min). There were three complications (10. 7%) ¿ one case each of cytotoxic edema, post-operative wound infection, and urinary tract infection. The rate of complication did not differ between groups. Conclusion: in contrast with optical neuronavigation, frameless and pinless electromagnetic image guidance allows the ability to track instrument depth in real-time. It may increase ventricular catheter placement accuracy and precision, and decrease operative times. Reported events: one patient experienced a urinary tract infection, which resolved with antibiotic therapy.
 
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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 Key10881845
MDR Text Key217678192
Report Number1723170-2020-03061
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 health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2020
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 Received11/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/22/2020 Patient Sequence Number: 1
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