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

Catalog Number 960-525

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

The site declined to provide patient information, per (b)(4) privacy laws.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect active stealth fighter inst.No parts have been received by manufacturer for analysis.On 03/01/2016 a medtronic representative, following-up at the site, confirmed the instrument was fractured during use.

Event Description

A medtronic representative reported that, while in a posterior spinal fusion procedure, the site's awl / probe / tap (apt) experienced recognition failure.The connector part was manipulated and the reported apt re-gained recognition normally.The surgeon opted to continue the procedure.After this issue, a good site was found to connect in order to continue, as the cable was partly fractured.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.

• 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 ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 5494933
• MDR Text Key: 40149127
• Report Number: 1723170-2016-00329
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 960-525
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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