MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM FUSION EM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number FUSION

Device Problem No Display/Image (1183)

Patient Problems Cerebrospinal Fluid Leakage (1772); Iatrogenic Source (2498)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

The investigation into this event is ongoing.

Event Description

A medtronic representative reported that during a cranial procedure the patient experienced a csf leak.The surgeon reported that the screen of the navigation system went "off" and acted weird so the surgeon re-registered the blade and everything was fine.No further details regarding the event or patient status were provided.The medtronic representative was unsure of what procedure was being performed but knows that the navigation system was in use.

Manufacturer Narrative

The issue was reviewed during the hardware engineering investigation meeting.No additional details were provided to explain the reported issue/malfunction.No hardware parts were replaced, at this time there is no confirmed allegation of deficiency related to hardware components.No further hardware investigation shall take place at this time.If additional information is received related to the hardware investigation the formal investigation will be re-reviewed.Recommend software review.The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.

Manufacturer Narrative

Correction: event date updated to proper value.

• Brand Name: SYSTEM FUSION EM
• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 6183454
• MDR Text Key: 62670387
• Report Number: 1723170-2016-05769
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169504394
• UDI-Public: 00643169504394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/23/2017; 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2016
• 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
• Patient Outcome(s): Required Intervention