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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) ADHESIVE PAD 9732500 HEAD TRACKER 25PK NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) ADHESIVE PAD 9732500 HEAD TRACKER 25PK NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9732500
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Skin Discoloration (2074); Skin Irritation (2076); Injury (2348); Iatrogenic Source (2498)
Event Date 06/09/2016
Event Type  Injury  
Manufacturer Narrative
Device lot number not available as the site discarded the product and did not provide the lot number. Device manufacturing date is dependent on lot number, therefore, unavailable. Return requested for suspect adhesive pad head tracker. This part was discarded by the site and will not be returned to manufacturer for analysis. No further issues have been reported.
 
Event Description
A medtronic representative received a report on (b)(6) 2016 from a site nurse that, while in a procedure on (b)(6) 2016, they removed the head frame adhesive from a patient and the adhesive left redness, blistering and a small amount of bruising on the patient's forehead. It was reported that following the surgery the redness and other issues dissipated with no further impact. No further details were provided. The surgeon had completed the procedure with the use of the navigation system. There was no delay of therapy. There was no impact on patient outcome.
 
Manufacturer Narrative
Additional information: a medtronic representative reported that they only used the patient sticker with the older style patient tracker. They did not use the headband or actual head frame, just the patient tracker stuck to the patient sticker. It was unknown how long the sticker was in place or what the start and end times were for that case. They said they treated this event as the patient had a sensitivity to adhesives. They created an action plan to screen future patients for adhesive sensitivities as well as use some kind of chemical protective barrier on those patients. Per further engineering review it was found that the instructions for use which accompanies the head frame contains warnings and contraindications for use of the head frame and head frame adhesive.
 
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Brand NameADHESIVE PAD 9732500 HEAD TRACKER 25PK
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
louisville, CO 80027-9710
7208902082
MDR Report Key5792411
MDR Text Key49490393
Report Number1723170-2016-01384
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 08/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9732500
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 Received07/21/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/13/2016 Patient Sequence Number: 1
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