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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7 INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC S7 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 05/04/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: psu kit 9735339r spectra rwk rohs, serial/lot: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2020-05-04 (b)(6) (rep, hcp): medtronic received information regarding a navigation system being used during a cranial resection procedure. It was reported that the camera was flickering during the case. The cable was unplugged and re-plugged in and the issue stopped. There was no patient. There was no reported delay.
 
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Brand NameS7
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 Key10030897
MDR Text Key190111464
Report Number1723170-2020-01381
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
Type of Report Initial,Followup,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
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 Received08/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/14/2012
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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