MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) WRKSTN, 9732585, STLTHSTN INAV II; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	I7
Medical Device Problem Codes	No Display/Image (1183); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.On 05/02/2016 a medtronic representative performed a navigation system check-out, software and instruments areas passed.Hardware test failed.Camera was not responding.Return requested for suspect camera.Replacement camera shipped to site.Medtronic investigation of returned suspect device finds that the positioning sensor unit (psu) was received poorly packaged and has many scratches on the housing and lenses.When connected to a known good system the psu beeped constantly at power-up and could not establish communication.The psu is not functional.Electrical failure.The psu failed an aak test at.67 mm with a passing threshold of.60 mm.A high line separation was also reported at 3.02 mm.The psu is not usable.Failed diagnostic test.Hardware investigation was completed.This camera issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.Return requested.Replacement optical power/comm cable shipped to site.Medtronic investigation of returned suspect cable finds the cable to be in good condition with no apparent physical damage.However, a continuity check revealed an open from pin 5 of the db9 connector to pin 5 of the p1 lemo connector.Electrical failure.Hardware investigation was completed.This cable issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.No further issues have been reported.
Event or Problem Description
A medtronic representative reported a navigation system camera that was not showing status, power or any type of communication.The camera was not responding to the navigation system properly.No further details regarding the behavior, or specifically when it occurred, were provided.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
A medtronic representative reported that the reported event occurred in (b)(4).

• Brand Name: WRKSTN, 9732585, STLTHSTN INAV II
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6308915
• Report Number: 1723170-2017-00330
• Device Sequence Number: 443255
• Product Code: HAW
• UDI-Device Identifier: 00613994110831
• UDI-Public: 00613994110831
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2017

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: I7
• Device Catalogue Number: 9732585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1