MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735665

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identification (udi) unavailable.Device manufacturing date is unavailable.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the cross-hairs were slightly skewed in the trajectory 1 and 2 views.The trajectory 1 was skewed to the right and 2 was skewed to the left.There was no delay to surgery and no impact on patient outcome.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.

Manufacturer Narrative

A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue.Analysis found that the details and image provided by the site do not provide enough information to determine whether a software anomaly contributed to the reported behavior.Analysis found that the analysis was inconclusive and probable cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 PREMIUM 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7664884
• MDR Text Key: 113282654
• Report Number: 1723170-2018-03172
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735665
• 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: 03/29/2018
• 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: 15 YR
• Patient Weight: 34