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

Model Number 9735665

Device Problems No Device Output (1435); Communication or Transmission Problem (2896)

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

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier not available from the site.No parts have been returned to the manufacturer for analysis.Device manufacturing date is unavailable.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the surgeon had difficulty registering the patient.Site utilized a scan for an infant 5 months prior to case and surgeon was unable to complete a good registration.Surgeon opted to abort navigation because the system was only picking up one side of the patient¿s anatomy.There was a reported delay to procedure of 30 minutes due to this issue.There was no impact to patient.

Manufacturer Narrative

Add: patient identifier.Correction: initial reporter.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Follow-up with the rep determined that the issue has not occurred since the initial incident.

• 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: erika mitchellette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7842141
• MDR Text Key: 119156606
• Report Number: 1723170-2018-04366
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/14/2019

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: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• 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: 6 MO
• Patient Weight: 7