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

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.

• Brand Name: ADHESIVE PAD 9732500 HEAD TRACKER 25PK
• Type of Device: NEUROLOGICAL 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 Key: 5792411
• MDR Text Key: 49490393
• Report Number: 1723170-2016-01384
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974187
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9732500
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 50