MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL; SEE H10)

Model Number S7

Device Problems No Device Output (1435); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.The initial report occurred on (b)(6) 2016 and was found to be a non-reportable malfunction based on the information available.On 10-nov-2016, new information was available through evaluation of the returned device and the decision was changed to a reportable malfunction.No procode, common device name and/or 510(k) provided as this device is not released for distribution in the united states.A medtronic representative went to the site to test the equipment and found that the polaris spectra system control unit (scu) required replacement.After replacing the scu the hardware, software, and instruments passed the system checkout.The system was fully functional.Investigation of returned suspect scu finds that when connected to a known good system the scu performed as expected without issue.However, a check of the event log revealed an intermittent sensor current issue.When the sensor current was low the scu would stop communicating with the psu.Then the sensor current would recover and communication would re-establish.The reported issue was confirmed to be caused by an electrical failure.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A medtronic representative reported that during a cranial biopsy the small active cranial frame had a recognition failure when being used with the navigation system.The surgeon completed the procedure with the use of the navigation system and with an alternative frame.There was no impact on patient outcome.There was a reported delay to the procedure of less than 1 hour due to this issue.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: SEE H10)
• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 6160063
• MDR Text Key: 62386199
• Report Number: 1723170-2016-05751
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• 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