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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NON-INVASIVE PATIENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NON-INVASIVE PATIENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9734887
Medical Device Problem Codes Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/22/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
 
Event or Problem Description
A medtronic representative reported that, while in a functional endoscopic sinus surgery (fess), some adhesive material from the patient tracker remained on the patient rather than on the tracker.The patient's forehead was reported to be a bit red following the removal.No additional information was provided.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.
 
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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 Key6508124
Report Number1723170-2017-01731
Device Sequence Number11079902
Product Code HAW
UDI-Device Identifier00643169488113
UDI-Public00643169488113
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K141833
Number of Events Summarized1
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
Report Date (Section B) 04/20/2017
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 Physician
Device Catalogue Number9734887
Device Lot Number160815C
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/22/2017
Initial Report FDA Received Date04/20/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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