MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Computer Software Problem (1112); Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A medtronic representative inspected the navigation system on-site, and a software investigation was completed.On-site, the reported issue was not replicated.The navigation system functioned normally during inspection, and no malfunction could be confirmed.The software investigation was similarly inconclusive.Probable cause could not be determined based on the information available.A full navigation system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A medtronic representative reported that during a spinal fusion procedure, the navigation system was inaccurate, while being used in conjunction with a particular c-arm.The magnitude and direction of the alleged inaccuracy was not provided.The surgeon opted to complete the procedure without the use of the navigation system.There was a reported delay to the procedure of less than 1 hour due to this issue.The procedure was completed successfully without the navigation system and the patient was not impacted.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of 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: nicholas mcnabb ; 826 coal creek circle; louisville, CO 80027 ; 7208902439
• MDR Report Key: 6205692
• MDR Text Key: 63373806
• Report Number: 1723170-2016-05931
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2012
• 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
• Patient Age: 58 YR
• Patient Weight: 86