MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Device Inoperable (1663); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A part shipment was placed for a position sensor unit (psu), sensor control unit (scu) and two connection cables.A medtronic representative went to the site to test the equipment.While performing a navigation system check-out, the medtronic representative, confirmed that the navigation system psu would not power on.There was no optical communication so the optical procedure could be performed.The medtronic representative deduced the psu required replacement.After psu replacement, the medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.Return requested for suspect positioning sensor unit (psu).Manufacture date apr 2012.The returned psu powered up without the amber fault light on.The psu functioned normally for several minutes, and then the fault light came on.A check of the event log revealed a history of illuminator current failure.The illuminator current has been moving in and out of range since (b)(6) 2013.The psu failed an aak test at.50 mm with a passing threshold of.35 mm.The laser battery is also very low.The hardware investigation was completed and revealed that this issue was related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.The sensor control unit (scu) and two connection cables were returned unused.

Event Description

A site representative reported that the positioning sensor unit (psu) was not receiving any power and therefore was not turning on.No patient was present during the time of the reported incident.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: jasmine birlew ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6188969
• MDR Text Key: 62857034
• Report Number: 1723170-2016-02232
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2012
• 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