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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)
Patient Problem No Patient Involvement (2645)
Event Date 11/04/2016
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Return requested. Replacement lead acid 24v 34w battery shipped to site 11/04/2016. Suspect battery has not been received by manufacturer for analysis. Return requested. Replacement selectable ups shipped to site 11/04/2016. Medtronic investigation of returned suspect ups finds that when connected to a known good system, the ups was able to charge a known good battery and run from battery power. No problem found. Device found to be fully functional. On 11/05/2016 a medtronic representative, following-up at the site, reported that the navigation system powering down behavior continued after part replacement. After uninstalling/reinstalling the software, the system functioned as expected. Return requested. Replacement positioning sensor unit (psu) shipped to site 11/11/2016. Medtronic investigation of returned suspect psu was received with many nicks and scratches. The psu powered-up without the fault light illuminated. A check of the event log revealed an intermittent history of hardware fault. The illuminator current has been moving in and out of range. Otherwise, the psu passed an aak test at. 14 mm with a passing threshold of. 35 mm. System fault code - illuminator current out of range - electrical failure. Hardware investigation was completed. This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.
 
Event Description
A medtronic representative reported that a site's navigation system was power cycling on and off. Re-booting the navigation system restores normal function. No further details regarding the behavior, or specifically when it occurred, were provided. There was no patient present when this issue was identified.
 
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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
judith ericson
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6179500
MDR Text Key62678217
Report Number1723170-2016-05761
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2011
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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