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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 9732781
Device Problem Use of Device Problem (1670)
Patient Problems Skin Discoloration (2074); Skin Irritation (2076); Iatrogenic Source (2498)
Event Date 02/10/2017
Event Type  Injury  
Manufacturer Narrative
Additional information: patient id, age and gender provided.
 
Manufacturer Narrative
Patient information was not made available from the site. Manufacture date of the device could not be determined with the information provided. Instructions for use which accompany this product state: "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. " no parts have been replaced or returned. Surgeon has been educated on the risk of using this device for long periods of time when it is put on tightly.
 
Event Description
A medtronic representative reported that the 9732781 head tracker kit was put on in an otorhinolaryngological surgery for the paranasal sinus. The procedure lasted for about 7 hours. There seemed no issue soon after the surgery, however, on the following day, blisters and redness started appearing on the patient¿s forehead, where the device had been put on. The patient was treated by a dermatologist afterwards and the symptoms are improving. The rep had informed the physician prior to the procedure that skin irritation might occur after a long surgery. The rep saw the physician once again on (b)(6), and confirmed that the physician was aware of the possible side effect of using the device for such an extended amount of time.
 
Manufacturer Narrative
Additional information: further investigation was conducted. In addition to instructions for use which accompany this product already reported on initial mdr, it also states, "always screen the patient for adverse reaction to all patient contacting materials, especially adhesives, prior to the procedure. ".
 
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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
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6397823
MDR Text Key102113327
Report Number1723170-2017-01023
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994155573
UDI-Public00613994155573
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K974187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 08/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9732781
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 Received07/26/2017
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: 03/11/2017 Patient Sequence Number: 1
Treatment
(B)(4).
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