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

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a navigation system. It was reported that whilst performing a biopsy case a rep expressed not remembering whether he had made a new point of entry before navigating the needle with the surgeon. While they were actively sampling, the rep was advised to put the vertec probe back in the entry point to confirm their accuracy to their plan. When they put the vertec probe in the aiming device, it was reporting 10mm from target. The surgical team were then having trouble getting the plan to realign to the original target and had to made a new plan on the spot. Superficial bleeding was reported. There was less than an hour of delay.

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a navigation system. It was reported that whilst performing a biopsy case a rep expressed not remembering whether he had made a new point of entry before navigating the needle with the surgeon. While they were actively sampling, the rep was advised to put the vertec probe back in the entry point to confirm their accuracy to their plan. When they put the vertec probe in the aiming device, it was reporting 10mm from target. The surgical team were then having trouble getting the plan to realign to the original target and had to made a new plan on the spot. Superficial bleeding was reported. There was less than an hour of delay.

• 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: 12984206
• MDR Text Key: 285493413
• Report Number: 1723170-2021-02873
• 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,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/13/2021
• 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: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse