MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number I7

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

On 11/11/2016 software analysis was unable to determine probable cause with the information provided.It is likely that the stingray may have moved during the movement of the patient head.On 11/21/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.No further issues have been reported.

Event Description

A site physician reported that, while in a cranial resection procedure, the surgeon alleged an inaccuracy occurred.They had registered in the supine position and after they moved the patient's head they were 2 centimeters off.The surgeon opted to discontinue the use of their navigation system to continue the procedure to completion.There was no delay of therapy.There was no impact on patient outcome.

Manufacturer Narrative

Correction to device unique device identifier (udi) now provided.The instructions for use (ifu) which accompanies this device contains the following warnings regarding frame movement: warning: do not bump or reposition the patient reference after registration.Movement of the patient reference will result in inaccurate navigation.If the patient reference moves in relation to the patient anatomy at any time after registration, you must re-register.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 6139600
• MDR Text Key: 61310226
• Report Number: 1723170-2016-05620
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169486645
• UDI-Public: 00643169486645
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: I7
• Device Catalogue Number: 9734060
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1