MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FRAME CRANIAL ACTIVE HC; INSTRUMENT, STEREOTAXIC

Model Number	9733881
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided at the time of report.As returned, the lemo connector shell had been removed and the pin housing.The shell inserted incorrectly.One of the pins in the pin housing is broken off.The frame is not functional as is.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system that was used during a catheter placement procedure.It was reported that the site was having issues with an active cranial reference frame not connecting to the navigation system.The cranial reference frame is damaged; fracture was suspected.The procedure was completed using another active cranial frame.There was no reported delay or impact on patient outcome.

• Brand Name: FRAME CRANIAL ACTIVE HC
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9967500
• Report Number: 1723170-2020-01231
• Device Sequence Number: 2092934
• Product Code: HAW
• UDI-Device Identifier: 00643169545588
• UDI-Public: 00643169545588
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: 9733881
• Device Catalogue Number: 9733881
• Device Lot Number: 160714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1