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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Irritation (2076); Tissue Damage (2104); Iatrogenic Source (2498)
Event Date 03/01/2017
Event Type  Injury  
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 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.
 
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.
 
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Brand NameNON-INVASIVE PATIENT TRACKER
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
amos jarrette
826 coal creek circle
attn:product quality experienc
louisville, CO 80027
7208902082
MDR Report Key6449280
MDR Text Key71390854
Report Number1723170-2017-01380
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00643169488113
UDI-Public00643169488113
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 06/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number9734887
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/31/2017 Patient Sequence Number: 1
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