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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC Stealthstation® S7¿ INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problems Material Integrity Problem (2978); Protective Measures Problem (3015)
Patient Problem No Patient Involvement (2645)
Event Date 02/25/2019
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. Testing revealed that after the cable was replaced, the issue was resolved. The system then passed the system checkout and was found to be fully functional. The power cable was returned to the manufacturer for analysis. Analysis found that the ground prong was broken off and was missing. Analysis found that the reported event was related to a mechanical issue. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported outside of a procedure that the system had a missing ground prong. No patient was present.
 
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Brand NameStealthstation® S7¿
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 Key8455330
MDR Text Key139971817
Report Number1723170-2019-01373
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
Reporter Occupation
Type of Report Initial
Report Date 03/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/13/2013
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2012
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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