MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FIELD GENERATOR 9731203 EM MOBILE; INSTRUMENT, STEREOTAXIC

Model Number	9731203
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the cart 9733858 s7 assembled staff 220v (serial #: (b)(4)9) found that it passed the work order.Analysis of the field generator 9731203 em mobile (lot #: 0400002290) found an axiem emitter failure.The reported problem was confirmed.Emitter and axiem box reported a communication error when the field generator was connected to the axiem box.Em interface showed a fault on coil 9.Product event summary #s7 axiem box damaged product analysis #237243334: mnav findings and conclusions: reported problem was confirmed.Emitter and axiem box reported a communication error when the field generator was connected to the axiem box.Em interface shows a fault on coil 9.Mnav methodology: functional testing;visual/physical examination mnav detail: awaiting field response/info, mnav usability: false, mnav able to duplicate the issue?: yes.Mnav bai/oobf?: false.Mnav failure mode: electrical.Mnav failure mechanism: red status/no tracking.Other relevant device(s) are: product id: 9733858, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system event having occurred in servicing.It was reported that instruments could not be registered, the camera was not working.No patient present.

• Brand Name: FIELD GENERATOR 9731203 EM MOBILE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8661294
• Report Number: 1723170-2019-02842
• Device Sequence Number: 16729413
• Product Code: HAW
• UDI-Device Identifier: 00885074240091
• UDI-Public: 00885074240091
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9731203
• Device Catalogue Number: 9731203
• Device Lot Number: 0400002290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 06/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1