MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SKULL-MOUNT PATIENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	S7
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative.The system passed a system checkout and was determined to be fully operational.The tracker was returned to the manufacturer.Functional testing found that the component would no track when connected to a known good system.The tracker was found to be malfunctioning.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that intra/peri-operatively during the navigate task of an electrode and lead placement procedure, the dynamic reference frame (drf) would flicker in and out of view.The site stated this is the only instrument that seems to be affected.Drf flickered for entire case.After the case, the site tested the drf holding it in the air off the bed with the emitter held up to it, and the drf still flickered.The site attempted multiple drfs, the same result occurred.All other instruments tracked completely fine.The site also stated they suspects it was the bed, per the previous case where this happened ((b)(4)).There was a delay to the procedure of less than one hour.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
Additional information: it was reported that the axiem box was replaced and there have been no complaints regarding patient trackers since the replacement.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SKULL-MOUNT PATIENT TRACKER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7832330
• Report Number: 1723170-2018-04329
• Device Sequence Number: 19166971
• Product Code: HAW
• UDI-Device Identifier: 00643169490017
• UDI-Public: 00643169490017
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: S7
• Device Catalogue Number: 9735300
• Device Lot Number: 180425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 MO
• Patient Weight: 1