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

Catalog Number 960-556

Device Problem Bent (1059)

Patient Problems Cerebrospinal Fluid Leakage (1772); Therapeutic Response, Decreased (2271); Injury (2348); Iatrogenic Source (2498)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.During the onsite inspection, the medtronic representative reported that the system's accuracy was verified.It was found that the passive planar blunt probe was bent.The part was discarded onsite and therefore unavailable for further analysis.A successful system checkout was performed which verified that the issue had been resolved.This report was generated from the incident filed in mdr 1723170-2017-00466.

Event Description

A medtronic representative reported that while the surgeon was performing a tracer registration with the patient prone the system was accurate.The site draped the patient and put on a sterile frame.The surgeon attempted to align the trajectory and the original burr-hole was not sufficient so the burr-hole was moved.The surgeon locked the trajectory and set the depth on the biopsy needle.When the biopsy needle was inserted it hit cerebrospinal fluid (csf) fluid.After un-draping the patient the site put on the reference frame and noticed a 1 cm inaccuracy.It was noted that the tracer pattern was focused on the predominately on the forehead.There was no impact from the csf leak to the patient.The surgeon was able to control the leak.The delay in surgery was an hour.The surgery was discontinued and the biopsy was not completed.The patient was rescheduled for a second surgery.The delay in surgery was an hour.

• Brand Name: PASSIVE PLANAR BLUNT PROBE
• 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: jasmine birlew ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6364935
• MDR Text Key: 68533238
• Report Number: 1723170-2017-00864
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00673978090122
• UDI-Public: 00673978090122
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K972398
• 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: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 960-556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 91