MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL; SIMILAR DEVICE: NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Computer Software Problem (1112); Device Inoperable (1663); Application Program Problem (2880)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been returned to the manufacturer for analysis.Device manufacture date is not available at time of filing.A medtronic representative went to the site to test the equipment.Testing revealed that the system regained functionality upon replacement of the central processing unit (cpu), however the computer was not returned to the manufacturer for analysis.Systems checkout was performed and system was functioning as intended.

Event Description

Medtronic received information regarding a navigation device being used for outside a procedure.The issue occurred preoperatively.It was reported that the computer was becoming unresponsive whenever they attempted to import exams.There was no patient present when this issue was identified.

Manufacturer Narrative

Device manufacture date provided.Correction: product, unique device identification (udi) and related fields updated to proper value.No 510(k) provided as this device is not released for distribution in the united states.The computer for the navigation system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: SIMILAR DEVICE: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7659539
• MDR Text Key: 113183622
• Report Number: 1723170-2018-03116
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450951
• UDI-Public: 00613994450951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1