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

Catalog Number	9734887
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Irritation (2076); Tissue Damage (2104); Iatrogenic Source (2498)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: per further engineering review, the reported event was hazard coded with a minor harm code.Review of the biocompatibility testing of the device found that the device passed the irritation index.No further investigation shall occur at this time.
Event or Problem Description
A medtronic representative reported that the non-invasive patient tracker produced "skin damage" on the patient's forehead.The patient was in a prone position for the seven hour surgery.The rep postulated that the patient tracker was not making direct contact with the horseshoe headholder, but was unable to visually confirm this during the surgery.The system performed as expected throughout the case.The skin damage was identified one day after the surgery and the hospital was unable to specify what type of skin damage occurred.
Additional Manufacturer Narrative
Additional information: per further engineering review, the reported event was hazard coded with a minor harm code.Review of the biocompatibility testing of the device found that the device passed the irritation index.No further investigation shall occur at this time.

• Brand Name: NON-INVASIVE 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: 6449280
• Report Number: 1723170-2017-01380
• Device Sequence Number: 16298963
• Product Code: HAW
• UDI-Device Identifier: 00643169488113
• UDI-Public: 00643169488113
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9734887
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Weight: 18