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

Model Number 9733856

Device Problems Imprecision (1307); Mechanics Altered (2984)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9735585, serial/lot #: unknown, if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a cyst fenestration procedure.It was reported that the surgeon felt inaccurate when they were in the brain.The surgeon then noticed that the articulating arm was loose.There was a path in the brain from a previous procedure that the surgeon had the passive catheter introducer aligned to, so the surgeon gently pushed on the articulating arm until navigation on the system aligned with where the surgeon was physically touching in the brain.The inaccuracy was reported to be about.5 mm.There was a less than hour surgical delay and no impact on patient outcome.

• Brand Name: STEALTHSTATION S7 NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11752915
• MDR Text Key: 248216392
• Report Number: 1723170-2021-01155
• 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: Physician
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2013
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2012
• 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: 47 YR
• Patient Weight: 86