MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PROBE 960-556 PLANAR PASSIVE BLUNT; INSTRUMENT, STEREOTAXIC

Model Number 960-556

Device Problem Output Problem (3005)

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

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Onsite functional and visual examination was performed by a manufacturer representative on the navigation system.It was determined that the navigation system was functioning as designed.Troubleshooting after the reported event performed by the representative noted that the distance to divot error was 1.9.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a cranial resection.It was reported that the site was having difficulty tacking and verifying their passive planar probe.This occurred during verifying their instruments and registering the patient.The site was seeing the instrument flash occasionally.30 min delay.Patient present.The representative tested the probe by monitoring the changes in the geometry error as he covered each sphere.The geometry error never changed dramatically and was in the.2 mm range.He placed the site's spheres on the probe he was able to replicate the flashing issue.The representative noted the likely cause is the site not replacing the spheres on the non-sterile probe.

• Brand Name: PROBE 960-556 PLANAR PASSIVE BLUNT
• 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: 9666944
• MDR Text Key: 178371246
• Report Number: 1723170-2020-00358
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 960-556
• Device Catalogue Number: 960-556
• Device Lot Number: 170127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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: 57 YR
• Patient Weight: 82