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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 Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. A medtronic representative went to site to test the equipment. Representative reported that the system was functioning and was unable to replicate the reported issue. Positioning sensor unit (psu) was replaced as a preventive action. A system checkout was performed and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The positioning sensor unit (psu) has not been received by the manufacturer for evaluation.
 
Event Description
A site representative reported that during cranial resection, after a while the positioning sensor unit (psu) of the navigation system did not track instruments properly after a successful registration. No noise or beeps were noticed from the camera by site. The procedure was completed without the use of navigation. There was no delay to procedure. No impact on patient outcome.
 
Manufacturer Narrative
Correction: product, unique device identification (udi) and associated fields updated to proper value.
 
Manufacturer Narrative
The positioning sensor unit (psu) was returned to the manufacturer for analysis. Analysis found that when connected to a known good system, the positioning sensor unit (psu) powered up without the amber fault light on. A check of the event log did not reveal any adverse events. Positioning sensor unit (psu) failed accuracy test. Analysis found that the reported event was related to a electrical issue. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
Manufacturer Narrative
Correction: product and related fields 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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7341469
MDR Text Key102481299
Report Number1723170-2018-01141
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2009
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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