MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SMALL ACTIVE CRANIAL FRAME LONG CABLE; INSTRUMENT, STEREOTAXIC

Model Number 9733881

Device Problems Material Integrity Problem (2978); Output Problem (3005)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

No devices were returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside of procedure.The information received was contradicting and we are following up to confirm the information.It was reported that one of the led lights had a recognition failure.The procedure was completed with the continuous use of the frame.The site was able to complete the procedure with the use of the frame.There was no patient present when this issue was identified.

Manufacturer Narrative

Analysis on the returned active frame resulted in an electrical failure being found through functional testing and visual/physical examination.Analysis states that, when connected to a known good system, it was found that led #3 was not firing.Otherwise, the frame returned good geometry and divot error readings.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient information was unavailable.Additional information: updated event description.Additional information: fda patient code has been updated to proper value.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was clarified that this issue occurred during a craniotomy procedure.It was noted that the active reference frame could be used for the time being even though one led did not recognize.There was no surgical delay due to this issue.There was no known or reported impact on patient outcome.

• Brand Name: SMALL ACTIVE CRANIAL FRAME LONG CABLE
• 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: 8175256
• MDR Text Key: 130691454
• Report Number: 1723170-2018-06336
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994480637
• UDI-Public: 00613994480637
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733881
• Device Catalogue Number: 9733881
• Device Lot Number: 140812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/18/2018; 02/11/2019
• Supplement Dates FDA Received: 01/15/2019; 02/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1