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

Model Number	9732500
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Skin Irritation (2076); Tissue Damage (2104)
Date of Event	09/26/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8026081
• Report Number: 1723170-2018-05423
• Device Sequence Number: 16583299
• Product Code: HAW
• UDI-Device Identifier: 00613994155559
• UDI-Public: 00613994155559
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K974187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: Health Professional
• Device Expiration Date: 05/10/2018
• Device Model Number: 9732500
• Device Catalogue Number: 9732500
• Device Lot Number: 0008866352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention