MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SMALL PASSIVE CRANIAL REFERENCE FRAME; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	961-337
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Therapeutic Response, Decreased (2271); Injury (2348); Iatrogenic Source (2498)
Date of Event	01/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier not available from the site.Patient age not available from the site.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 reference frame had post damage.The part was discarded onsite and therefore not available 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 or Problem 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: SMALL PASSIVE CRANIAL REFERENCE FRAME
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6365229
• Report Number: 1723170-2017-00903
• Device Sequence Number: 1251628
• Product Code: HAW
• UDI-Device Identifier: 00721902467783
• UDI-Public: 00721902467783
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 961-337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 91