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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 No Display/Image (1183); Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 03/22/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. On 03/27/2017 a medtronic representative performed a navigation system check-out, software and instruments areas passed. Hardware test failed. Surgeon monitor was losing signal and causes the monitor to go blank. Surgeon monitor cord was replaced. Issue resolved. Return requested. Replacement ext wide cable shipped to site 03/23/2017. Medtronic investigation of returned suspect cable finds it to be in good condition with no apparent physical damage. The cable passed a continuity test with no opens or shorts detected. No problem found. On 04/12/2017 a medtronic representative, following-up at the site, reported the staff stated that there were loose pins on the surgeon monitor plug and they had to manipulate it for the image to show on the monitor. No further issues have been reported.
 
Event Description
A medtronic representative received a report from a site that their navigation system surgeon monitor cable was damaged and they were not receiving video on the monitor. No further details regarding the damage, or how it occurred, were provided. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Correction: device manufacture date updated to proper value.
 
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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
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6503316
MDR Text Key73123294
Report Number1723170-2017-01676
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
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,Followup
Report Date 06/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2017
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 Manufacturer04/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2013
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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