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

Catalog Number	9733879
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Manufacturing date unavailable at the time of filing.No parts have been returned to the manufacturer for analysis.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the active probe was fractured.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Additional information: device manufacture date provided.Correction: unique device identification (udi) updated to proper value.The probe was returned to the manufacturer for evaluation.Testing found two leds on the probe would not communicate with the navigation system.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.

• Brand Name: LINEAR BLUNT PROBE HC
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7782355
• Report Number: 1723170-2018-04047
• Device Sequence Number: 11201698
• Product Code: HAW
• UDI-Device Identifier: 00763000053529
• UDI-Public: 00763000053529
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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 Catalogue Number: 9733879
• Device Lot Number: LOT 131111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2013
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1