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

Catalog Number	9732781
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Skin Discoloration (2074); Skin Irritation (2076); Iatrogenic Source (2498)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.".
Additional Manufacturer Narrative
Additional information: patient id, age and gender provided.

• Brand Name: ADHESIVE PAD 9732500 HEAD TRACKER 25PK
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6397823
• Report Number: 1723170-2017-01023
• Device Sequence Number: 16373319
• Product Code: HAW
• UDI-Device Identifier: 00613994155573
• UDI-Public: 00613994155573
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2017

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
• Operator of Device: Physician
• Device Catalogue Number: 9732781
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: 06/21/2017; 07/26/2017
• Initial Report FDA Received Date: 03/11/2017
• Supplement Report FDA Received Date: 07/19/2017; 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR