MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735669

Device Problem Human-Device Interface Problem (2949)

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

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9 735736, serial/lot #: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a function endoscopic sinus surgery (fess).It was reported that when trying to export the archive for another case, they received error code 64.The archive will not be able to be sent in.The representative (rep) was advised to delete the patient file.The rep also reported that the site would not allow him to send in the original dicom (digital imaging and communications in medicine) via disc.There was a delay of less than one hour and no impact to the patient.The error was due to a corrupt patient cd.

• Brand Name: STEALTHSTATION S8 SYSTEM
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10514377
• MDR Text Key: 206348052
• Report Number: 1723170-2020-02408
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169838918
• UDI-Public: 00643169838918
• 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
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2019
• 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: 41 YR