FDA Adverse Event Malfunction Summary report: N

S7 STEALTH NAVIGATION SYSTEM

MDR report key: 8723490 · Received June 21, 2019

Report

Report Number: 1723170-2019-03736
Event Type: Malfunction
Date Received: June 21, 2019
Date of Event: August 31, 2017
Report Date: June 21, 2019
Manufacturer: MEDTRONIC NAVIGATION, INC
Product Code: HAW
UDI-DI: 00613994450944
PMA / PMN Number: K050438
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WY, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733763, UDI#: ASKU. THE SYSTEM WAS SERVICED AT THE SITE AND FOUND TO BE FULLY FUNCTIONAL. THE SYSTEM PASSED CHECKOUT AND WAS RETURNED TO SERVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE IN A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO GET REGISTRATION TO PASS WHEN USING TOUCH N GO. MULTIPLE ATTEMPTS WERE MADE BUT WERE UNABLE TO GET A PASSING REGISTRATION. MEDTRONIC REPRESENTATIVE REVIEWED THAT PATIENT EXAM AND SUSPECTS THAT THERE WAS MOVEMENT. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF NAVIGATION. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO KNOWN IMPACT ON PATIENT OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
517075	S7 STEALTH NAVIGATION SYSTEM	INSTRUMENT, STEREOTAXIC	HAW	MEDTRONIC NAVIGATION, INC	9733856		00613994450944

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR