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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problems Electrical /Electronic Property Problem (1198); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
Patient age not available from the site. Udi and manufacture date not available for this instrument at time of filing. A medtronic representative went to the site to test the equipment. The hardware passed the system checkout. The system was found to be fully functional. No parts have been returned to the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation device being used for a catheter placement procedure. It was reported that when the device was disconnected from the wall power to be rolled into the room, the device shut down unexpectedly. The clinical specialist was not able to confirmed if the device was plugged in overnight to charge and noted that this was not an issue during his recent planned maintenance (pm). There was less than 10 minutes delay to surgery and no impact to patient outcome.
 
Manufacturer Narrative
Correction: serial number and contact provided.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
4066574730
MDR Report Key7598866
MDR Text Key111004922
Report Number1723170-2018-02769
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
Report Date 07/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
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 Received06/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2014
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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