FDA Adverse Event Malfunction Summary report: N

STEALTHSTATION S7 SYSTEM

MDR report key: 3953839 · Received July 23, 2014

Report

Report Number: 1723170-2014-00789
Event Type: Malfunction
Date Received: July 23, 2014
Date of Event: July 24, 2013
Report Date: July 24, 2013
Manufacturer: MEDTRONIC NAVIGATION, INC.
Product Code: HAW
PMA / PMN Number: K050438
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PATIENT IDENTIFIER NOT AVAILABLE FROM THE SITE. PATIENT AGE NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. THE DECISION TO FILE THIS REPORT WAS DERIVED FROM FINDINGS OF AN INTERNAL MANUFACTURER CAPA ADDRESSING DELAY OF THERAPY TO THE PATIENT. RMA ISSUED. REPLACEMENT COMPUTER SHIPPED TO SITE (B)(4) 2013. ORIGINAL COMPUTER NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS DUE TO SITE REGULATIONS. A SOFTWARE INVESTIGATION WAS COMPLETED. A REVIEW OF THE TRACER REGISTRATION WAS COMPLETED AND WAS FOUND TO BE NOT OPTIMAL AND THERE WAS AN APPARENT SHIFT FROM THE NOSE. SOFTWARE IS FUNCTIONING AS DESIGNED.

Description of Event or Problem · 1

A SITE REPRESENTATIVE REPORTED THAT, DURING A CRANIAL RESECTION PROCEDURE, THE SURGEON WAS UNABLE TO REGISTER THE PATIENT. THE SURGEON ATTEMPTED TO USE POINTMERGE AND TOUCH-N-GO REGISTRATION METHODS, HOWEVER, BOTH WERE UNSUCCESSFUL IN PASSING REGISTRATION. THE SURGEON THEN USED TRACER REGISTRATION, WHICH PASSED BUT WAS DEEMED 3CM INACCURATE. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME. THE DELAY TO THE PROCEDURE WAS APPROXIMATELY TWO HOURS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
431453	STEALTHSTATION S7 SYSTEM	NEUROLOGICAL STEREOTAXIC INSTRUMENT	HAW	MEDTRONIC NAVIGATION, INC.	S7

Patients

Seq	Age	Sex	Outcome	Treatment
1