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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2019
Event Type  malfunction  
Manufacturer Narrative
Medtronic representative went to site and performed a system checkout. It was found that the system continued to go unresponsive. The computer was replaced and the system passed checkout. Other relevant device(s) are: product #: 9734477, lot #: 1723643. 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 system went unresponsive a few times. They rebooted the system to get it working again. There was less than a 1-hour delay in the procedure. There was no patient impact related to the event.
 
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Brand NameCART 9733856 S7 STAFF ASSEMBLED 110V
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 Key9547934
MDR Text Key183517332
Report Number1723170-2020-00031
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/20/2011
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2011
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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