MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INST KIT 9730285 SCOPE PROBE; INSTRUMENT, STEREOTAXIC

Model Number 9730285

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that the computer of the navigation system was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a cranial resection procedure.It was reported that the scope probe was tracking intermittently.It was reported that all other instruments tracked successfully.The scope probe would track when it was near the reference frame but would track intermittently near the peripheral.They tried a second scope probe and new spheres with no change.The site does not use medtronic spheres.A medtronic representative was on site and tested the probes.They opened new spheres and both scope probes tracked throughout the volume without issue; the behavior was unable to be replicated.The length of extended surgical time was less than 1 hour.Navigation was aborted as a result of the event.There was no patient impact related to the event.

• Brand Name: INST KIT 9730285 SCOPE PROBE
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9532005
• MDR Text Key: 184664155
• Report Number: 1723170-2019-06221
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9730285
• Device Catalogue Number: 9730285
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 9 YR
• Patient Weight: 27