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

Model Number S7

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Return requested.Replacement mobile field generator shipped to site 11/14/2016.No parts have been received by manufacturer for analysis.On 11/15/2016 a medtronic representative, following-up at the site, reported the same issue was confirmed when the emitter was attached to another product.On 11/22/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.- no further issues have been reported.

Event Description

A medtronic representative reported that after delivery of the demo device, an operational check was performed for the cranial em (electromagnetic) system, during which the emitter and the axiem control box experienced a communication failure.The error message for the control box on the emitter details was ¿fault-axiem box system error cycle power on axiem box.¿ on the rear lcd of the control box, ¿7¿ was shown indicating that no anomaly was present.On the front side, the indicators of the main power was lit green.The error message on the emitter side was ¿fault-low drive current please contact technical support.¿ the same error message appeared when the emitter was connected to either port of the control box.When only the emitter was disconnected, the control box side returned to normal, displaying ¿connected.¿ suspecting a contact failure of the connection cable to the control box, the cable was reconnected to the ups and usb ports on the navigation system and then the system was re-started.The issue was not resolved and the error recurred repeatedly.The optical system was used instead of the em system.No further details regarding the behavior were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

The hardware investigation of the returned field generator found that the reported event was related to an electrical issue.The reported problem was confirmed.Emitter and axiem box reported a communication error when the field generator was connected to the axiem box.Eminterface showed a fault on coil 4.Performed coil continuity check with fluke 112 (itm 1113), verified coil #4 is open.Root cause attributable to open in the circuit of coil #4 causing the reported communication failure.The open may be caused either by the coil being open, or a break in the solder joint between the wires attached to the coil.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6148566
• MDR Text Key: 61553069
• Report Number: 1723170-2016-05675
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• 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,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2013
• 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