MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735665

Device Problems Environmental Compatibility Problem (2929); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation system. It was reported that the system shut down unexpectedly, and prompted error 64 after having completed registration. After the system shut down the system retained the registration. The procedure was delayed by less than one hour and there was no impact on patient outcome. Additional information was provided stating that the system was plugged into a known functional outlet when the shutdown occurred. This was a cranial tumor resection procedure.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9735737. If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: NEUROLOGICAL 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13026455
• MDR Text Key: 286604233
• Report Number: 1723170-2021-02914
• 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: Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse