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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 9735670, serial/lot #: (b)(4), udi#: (b)(4); product id: 9735796, serial/lot #: unknown. Onsite functional and visual examination was performed by a manufacturer representative. Hardware parts were replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar procedure. It was reported that the site's system during a clinical case was noted to power cycle on the camera cart pcoip screen. There was no allotted delay in the case and patient was present during the complaint.
 
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Brand NameSURGN CART 9735665 STEALTH S8 PREMIUM
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9810742
MDR Text Key183327156
Report Number1723170-2020-00815
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Device Lot Number71AB42C6J2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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