MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. PASSIVE PLANAR BLUNT PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 960-556

Device Problems Bent (1059); Device Stops Intermittently (1599); Device Issue (2379); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

A site registered nurse (rn) reported that, while in a cranial procedure, their passive planar probe was tracking intermittently.They successfully completed registration, however, the probe continued to flicker between green and red status.In trouble-shooting, the site staff confirmed that spheres were fully seated on posts and replaced the spheres with new spheres.Issue was not resolved.Geometry error fluctuated at.4 -.5.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient information was not made available from the site.Device lot number not made available.Device was available to be evaluated at the site, it was not returned to manufacturer for analysis.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.No parts have been received by manufacturer for analysis.A medtronic representative, following-up at the site, reported responding to the site later the day of the event.When arrived, patient registration was complete.The navigation part of the procedure went well and there was a short delay to the initial part of the case.The reported issue is likely the physician's technique with tracer registration that caused the intermittent issue described.The issue was resolved and physician used navigation perfectly.The probe was tested after the case to confirm all instruments checked out and found all were at normal variances and were tracking perfectly.We have completed 3 similar navigated cases with the same instruments and navigation system since this case, all have went perfectly.A second medtronic representative, reported that, although no medtronic representatives were present at the procedure to witness the intermittent issues, the probes were tested afterward and the reported issue was determined to be a user error.Reported issue could not be replicated.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

• Brand Name: PASSIVE PLANAR BLUNT PROBE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: arsalan rizvi ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902460
• MDR Report Key: 4758757
• MDR Text Key: 5784547
• Report Number: 1723170-2015-00570
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 960-556
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• 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