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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC ADHESIVE PAD 9732500XOM 25PK ENT INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC ADHESIVE PAD 9732500XOM 25PK ENT INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9732500
Device Problem Biocompatibility (2886)
Patient Problems Skin Irritation (2076); Tissue Damage (2104)
Event Date 09/26/2018
Event Type  Injury  
Manufacturer Narrative
Patient age and weight was unavailable from the site. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a cranial resection procedure. It was reported that hours after the surgery, the patient presented an 'affectation' in the skin of their forehead in the pressure area of the adhesive pad. Nothing was observed during the procedure; just a pressure mark associated with normal use. The 'affectation' on the patient's forehead was diagnosed as epidermolysis due to contact. The patient was finishing their surgery recovery in the intensive care unit (icu) and was being treated by a dermatologist. The doctor reported that the skin problem seemed like a second-degree burn, which was crusting, possibly caused by a reaction to the chemical agents.
 
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Brand NameADHESIVE PAD 9732500XOM 25PK ENT
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8026081
MDR Text Key125712843
Report Number1723170-2018-05423
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994155559
UDI-Public00613994155559
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K974187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/10/2018
Device Model Number9732500
Device Catalogue Number9732500
Device Lot Number0008866352
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/06/2017
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: 10/31/2018 Patient Sequence Number: 1
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