• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Material Frayed (1262)
Patient Problem No Patient Involvement (2645)
Event Date 03/17/2017
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. It was found that the axiem data power cable was working but visibly frayed. The medtronic representative replaced the data cable with a new cable and tested all ports on the axiem box. The navigation system passed the system checkout and was found to be fully functional. Issue resolved with part replacement. The power data cable was returned to the manufacturer for analysis. Investigation confirmed reported issue. Found outer coaxial ground shield was frayed near the lemo connector. The wires were exposed. The hardware investigation found that reported event was related to physical damage failure mode; the cable was cut and damaged. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
Event Description
A medtronic representative reported that the navigation systems axiem data power cable was visibly frayed. No further details regarding the damage, or how it occurred, were provided. There was no patient present when this issue was identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
oksana ditolla
826 coal creek circle
louisville, CO 80027
MDR Report Key6487849
MDR Text Key72660357
Report Number1723170-2017-01611
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 04/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-