STEALTHSTATION S7 SYSTEM

Report

Report Number: 1723170-2014-00602
Event Type: Malfunction
Date Received: May 23, 2014
Date of Event: April 24, 2014
Report Date: April 24, 2014
Manufacturer: MEDTRONIC NAVIGATION, INC.
Product Code: HAW
PMA / PMN Number: K050438
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4) 2014; A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. (B)(4) 2014; A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE TO TROUBLE-SHOOT, REPORTED BEING UNABLE TO REPLICATE THE INTERMITTENT TRACKING OF THE DRF. IT WAS NOTED THAT IN THE REPORTED PROCEDURE, THE SURGEON USED A LARGE NUMBER OF STAPLES WHEN DRAPING THE PATIENT WHICH MAY HAVE AFFECTED THE EMITTER VOLUME. SYSTEM WAS FUNCTIONING NORMALLY IN REGISTRATION WITH RESIN HEAD DEMO, AS WELL. RECOMMENDATIONS WERE MADE TO TURN OFF THE BERCHTOLD LIGHTS, OR POSITION THEM AWAY FROM THE EM TRACKING FIELD, TO AVOID THIS ISSUE IN FUTURE PROCEDURES. THE SITE AGREED TO MOVE THE LIGHTS FURTHER AWAY FROM THE FIELD. NO FURTHER LIKE ISSUES HAVE BEEN REPORTED.

Description of Event or Problem · 1

A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A PROCEDURE, AND AFTER DRAPING THE PATIENT, THE SITE WAS UNABLE TO TRACK THE DYNAMIC REFERENCE FRAME (DRF). TRACKING DETAILS SHOWED RED STATUS. WHEN PLACING THE STYLET NEAR THE DRF, IT TRACKED PROPERLY. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. IT WAS LATER REPORTED THAT THE PATIENT RETURNED TO THE OPERATING ROOM TO HAVE THE SHUNT REPOSITIONED. THE SURGEON COMPLETED THE SECOND PROCEDURE WITH NO ISSUES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
308443	STEALTHSTATION S7 SYSTEM	NEUROLOGICAL STEREOTAXIC INSTRUMENT	HAW	MEDTRONIC NAVIGATION, INC.	S7

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Required Intervention