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

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

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.".

Manufacturer Narrative

Additional information: patient id, age and gender provided.

• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6397823
• MDR Text Key: 69734226
• Report Number: 1723170-2017-01023
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994155573
• UDI-Public: 00613994155573
• 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: 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 Received: 03/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9732781
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2017
• 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 Sequence Number: 1
• Treatment: (B)(4).
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR