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

Model Number FUSION

Device Problems Erratic or Intermittent Display (1182); Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.On (b)(6) 2017 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On (b)(6) 2017 a medtronic representative, following-up at the site, confirmed the reported issue could not be replicated.Nothing appeared to be out of order.No action required.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative reported that a site's navigation system monitor was flickering.No further details regarding this issue, or specifically when it occurred, were provided.There was no patient present when this issue was identified.

• Brand Name: FUSION 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: judith ericson ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6562379
• MDR Text Key: 74996051
• Report Number: 1723170-2017-01822
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• 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
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2009
• 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