MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7¿; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9733856

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

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 salesforce c00239228 (hcp): medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the system had completely shutdown and it was unable to boot up.There was no patient present.

Manufacturer Narrative

Continuation of concomitant medical products: other relevant device(s) are: product id: 9 733627.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION® S7¿
• 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: 13102012
• MDR Text Key: 290547191
• Report Number: 1723170-2021-02969
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2021
• 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