MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. HEAD TRACKER ADHESIVE PAD 25PK; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9732500

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Discoloration (2074); Skin Irritation (2076); No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2014

Event Type  Injury  

Event Description

A medtronic representative reported that, while in an endoscopic sinus surgery (ess) using a navigation system and ear, nose & throat (ent) software, there were no issues.The surgeon completed the procedure with the use of the navigation system.After the procedure, a pressure ulcer was confirmed on the patient's forehead at the site where the head frame was placed.It was reported that the patient recovered from this symptom with pigmentation of the skin remaining.The surgeon stated the head frame seal may possibly have caused the pressure ulcer.There was no impact on patient outcome.

Manufacturer Narrative

The site declined to provide patient information, referencing japan's privacy laws.Device manufacturing date is unavailable.No parts have been returned to manufacturer for analysis; likely discarded at site as this is a disposable item.Biocompatibility - material intended for patient contact.No further issues have been reported.

Manufacturer Narrative

Correction: adverse event inadvertently not selected on the initial 3500a, corrected to adverse event/serious injury.A medtronic representative reported that the doctor diagnosed the patient with contact dermatitis.The patient is receiving follow-up treatment for skin pigmentation.The patient did not show any signs of redness or irritation around the adhesive pad prior to beginning the surgery.There was no evidence of an over-tightened strap.No further information was able to be obtained.Based on the description of the event and responses from the rep, hardware engineering found that the most likely cause of the observed swelling/irritation was a skin reaction due to the prolonged exposure to the adhesive pad.The adhesive used on the pad is medical grade and hypoallergenic, but a small percentage of the population may still exhibit sensitivity to the adhesive materials.The issue may have been enhanced by the reportedly lengthy surgery.No parts were returned for analysis.

Manufacturer Narrative

Device manufacturing date now provided.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

• Brand Name: HEAD TRACKER ADHESIVE PAD 25PK
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: nicholas mcnabb ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902439
• MDR Report Key: 4451436
• MDR Text Key: 5386335
• Report Number: 1723170-2015-00019
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,company repres
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9732500
• Device Lot Number: 0206513416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention