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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 9733857
Device Problems Human-Device Interface Problem (2949); Protective Measures Problem (3015)
Patient Problem No Patient Involvement (2645)
Event Date 09/10/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative visited the site and completed a system checkout. The camera cable was replaced and the system performed as intended. The cable was discarded and not returned for analysis. The device manufacture date is unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used outside a procedure. It was reported that there was a broken pin on the camera cable. It was reported that the cable damage prevented camera communication. There was no patient present when this issue was identified.
 
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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 Key8469216
MDR Text Key140452442
Report Number1723170-2019-01460
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733857
Device Catalogue Number9733857
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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