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

Catalog Number	9733881
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Return requested.Replacement cranial active frame shipped to site 02/09/2017.No parts have been received by manufacturer for analysis.On 03/08/2017 a medtronic representative, following-up at the site, reported the led light went out after an incision was made.The surgeon used a second instrument to complete the procedure.No further issues have been reported.
Event or Problem Description
A medtronic representative received a report that, while in a cranial procedure, an led light went out on a cranial active frame the site was using.No further details regarding this issue, or specifically when it occurred, were provided.To continue the procedure, the site used a back-up cable and a second instrument.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.
Additional Manufacturer Narrative
Device lot number and device manufacture date provided.
Additional Manufacturer Narrative
The hardware investigation of the returned active frame found that the reported event was related to an electrical issue.Reported problem was confirmed.Cranial frame was connected to a test system which indicated the number 4 led wasn't firing (lighting up).The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: ACTIVE 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: 6388034
• Report Number: 1723170-2017-01012
• Device Sequence Number: 942849
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2017

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: Physician
• Device Catalogue Number: 9733881
• Device Lot Number: 130221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 04/06/2017; 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1