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

Model Number S7

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

Site dr.(b)(6) declined to provide patient identifier, age and weight.D2 & g5) no procode, common device name and/or 510(k) provided as this device is not released for distribution in the united states.  (b)(4) 2016 a medtronic representative, following-up at the site, confirmed a second navigation system camera was brought in to be used in continuing the procedure.(b)(4) 2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported that, while in a spinal fusion procedure for c2/3.Prior to procedure, while planning was checked with the physician, abnormal sound occurred from the navigation system.The camera repeatedly connected and disconnected.A pointer was held up, however, had recognition failure.The "×" mark was indicated for all items on verify instrument screen.It was confirmed that there was no issue with polaris spectra system control unit (scu) connection.Green light on the left side and center on the camera blinked without issue.The navigation system was re-started, however.Did not react.The medtronic representative explained the situation to the physician and suggested the physician to stop using the device, however, the physician declined and asked to resolve the issue.When only the navigation system camera was replaced, the orange light (warning sign) on the right side of the camera was blinking, however, there was recognition without issue.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was greater than one hour before continuing.There was no impact on patient outcome.

• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6178074
• MDR Text Key: 62803325
• Report Number: 1723170-2016-05760
• 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: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2011
• 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