FDA Adverse Event Malfunction Summary report: N

STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

MDR report key: 2920946 · Received January 17, 2013

Report

Report Number: 1723170-2013-00041
Event Type: Malfunction
Date Received: January 17, 2013
Date of Event: December 21, 2012
Report Date: December 21, 2012
Manufacturer: MEDTRONIC NAVIGATION, INC.
Product Code: HAW
PMA / PMN Number: K050438
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

SOFTWARE INVESTIGATION COMPLETED. FINDINGS ARE THERE IS STRONG INDICATION THAT THERE WAS SHIFT IN THE PATIENT'S ANATOMY, AND THUS THE EXAM WOULD BE SUSPECT FOR USE WITH NAVIGATION. SOFTWARE IS FUNCTIONING AS DESIGNED.

Description of Event or Problem · 1

A MEDTRONIC REPRESENTATIVE REPORTED AN ALLEGED INACCURACY WHILE IN A CRANIAL PROCEDURE. THE 3D MODEL WAS REPORTED TO BE LACKING QUALITY, AND THE PATIENT'S ANATOMY HAD BEEN COMPRESSED IN THE SCANNER DURING A POSTERIOR FOSSA CRANIOTOMY. THE SURGEON WANTED TO CONTINUE WITHOUT EDITING THE 3D MODEL. A POINTMERGE REGISTRATION WITH FIDUCIALS WAS PERFORMED SUCCESSFULLY. WHEN CHECKING ACCURACY, THE SURGEON ALLEGED IT WAS [A FEW MILLIMETERS] INACCURATE; THE SURGEON PROCEEDED TO NAVIGATE WITH THIS KNOWLEDGE. BIOPSY SAMPLE WAS NOT DIAGNOSTIC. A MEDTRONIC REPRESENTATIVE CONFIRMED LIKELY SHIFT AND NO GUARANTEE OF ACCURACY ON SAME EXAMS. A SECOND BIOPSY SAMPLE WAS OBTAINED AND THE TUMOR WAS SUCCESSFULLY REMOVED. THE SURGEON CHOSE TO COMPLETE THE PROCEDURE WITH THE USE OF THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26647	STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM	NEUROLOGICAL STEREOTAXIC INSTRUMENT	HAW	MEDTRONIC NAVIGATION, INC.	TREON

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR