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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 Material Frayed (1262); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 06/20/2016
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Return requested. Replacement external axiem power/data cable shipped to site on (b)(6) 2016. Medtronic investigation of returned suspect external axiem power/data cable confirms the reported issue. Found communication cable for the axiem box is frayed and the wires are exposed. Cable was still fully functional, only the outer coax was damaged. Cable cut and damaged. Failure: physical damage. Hardware investigation was completed. This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database. On 06/30/2016, a medtronic representative performed a navigation system check-out, software and instruments areas passed. Hardware test failed. Axiem power cable failed. Replaced cable. Issue resolved. System performed as intended. No further issues have been reported.
 
Event Description
A medtronic representative reported that a site's navigation system power and communication cable for the axiem box was frayed and the wires were exposed. No further details regarding the damage, or how 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 Key5806897
MDR Text Key49954928
Report Number1723170-2016-01422
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 07/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2016
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 Manufacturer07/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2012
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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