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

Model Number S7

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A software analysis was performed using the patient exams.The manufacturer representative noticed that the spacing in the slices were different when low and high dosages meet.The manufacturer representative suggested that the site uses the same spacing throughout even when changing to a lower dosage.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the images loaded were missing anatomy when viewed in the dicom.Loading on the cranial application results in images missing from the top of the head.There was no patient present when this issue was observed.

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 behavior described is the intended behavior of the software.The exams were not to protocol, with non-contiguous slices.Software is functioning as designed.Analysis found that the software functioned as designed.If information is provided in the future, a supplemental report will be issued.

• 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: parker desautel ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7843330
• MDR Text Key: 119106887
• Report Number: 1723170-2018-04363
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2013
• 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