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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734056
Device Problem Environmental Compatibility Problem (2929)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 9 733625, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used outside of a procedure. The navigation system suddenly turned off during preoperative planning. The power switch was pressed again, but there was no response. It was confirmed the power did not turn on due to a malfunction with the uninterruptible power supply (ups). There was no patient involvement.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13119000
MDR Text Key282975625
Report Number1723170-2021-02992
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number9734056
Device Catalogue Number9734056
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2017
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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