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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9732500
Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)
Patient Problems Skin Irritation (2076); Iatrogenic Source (2498)
Event Date 12/14/2015
Event Type  malfunction  
Manufacturer Narrative
Patient information was refused to be provided by the surgeon. Device lot number, or serial number, unavailable. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. Suspect adhesive pad has not returned to manufacturer for evaluation, return not expected. No further relevant issues reported. The instructions for use that accompany the device contains warnings and contraindications regarding use of this instrument: "contraindications the em ent head frame is not recommended for: patients with circulatory diseases whose skin may be prone to damage from pressure from the silicone pads; patients with topical treatments or oils that cannot/should not be removed; unusual soft tissue sensitivity or damaged tissue at or near the intended mounting areas. " "warning: always screen the patient for adverse reaction to all patient contacting materials, especially adhesives, prior to the procedure. " "warning: do not over tighten the strap. Always look for signs of excessive pressure surrounding the em ent head frame site. Over-tightened straps may cause pressure-related injuries such as bruising, skin marks, or nerve damage. ".
 
Event Description
A medtronic representative received a report from the site that after a functional endoscopic sinus surgery (fess) the adhesive pad for head tracker instrument was potentially causing irritation of the patients skin. There was no reported delay to the procedure due to this issue. The surgeon had completed the procedure with the use of the navigation system when the issue was observed. There was no known impact on patient outcome.
 
Manufacturer Narrative
Device lot number and expiration date now provided. Device manufacturing date now provided.
 
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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
kristianna bilan
826 coal creek circle
louisville, CO 80027
7208902338
MDR Report Key5358057
MDR Text Key35620285
Report Number1723170-2016-00026
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 02/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/22/2016
Device Catalogue Number9732500
Device Lot Number0209905208
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 Received02/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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