MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC ADHESIVE PAD 9732500XOM 25PK ENT INSTRUMENT, STEREOTAXIC

Model Number 9732500

Device Problem Biocompatibility (2886)

Patient Problems Skin Irritation (2076); Tissue Damage (2104)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

Patient age and weight was unavailable from the site. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a cranial resection procedure. It was reported that hours after the surgery, the patient presented an 'affectation' in the skin of their forehead in the pressure area of the adhesive pad. Nothing was observed during the procedure; just a pressure mark associated with normal use. The 'affectation' on the patient's forehead was diagnosed as epidermolysis due to contact. The patient was finishing their surgery recovery in the intensive care unit (icu) and was being treated by a dermatologist. The doctor reported that the skin problem seemed like a second-degree burn, which was crusting, possibly caused by a reaction to the chemical agents.

• Brand Name: ADHESIVE PAD 9732500XOM 25PK ENT
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8026081
• MDR Text Key: 125712843
• Report Number: 1723170-2018-05423
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K974187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/10/2018
• Device Model Number: 9732500
• Device Catalogue Number: 9732500
• Device Lot Number: 0008866352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/31/2018 Patient Sequence Number: 1