MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Irritation (2076); Injury (2348); Iatrogenic Source (2498)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

Patient information was not made available from the site.Non-invasive patient tracker biocompatibility - material intended for patient contact return requested for the suspect non-invasive patient tracker.No parts have been received by manufacturer for analysis.On 06/06/2016 a medtronic representative, following-up at the site, reported that the surgeon applied bacitracin on the wound.No further follow up required.On 06/23/2016 per the medtronic representative, the site declined to return the non-invasive patient tracker to the manufacturer for analysis, stating is remains hospital inventory.No parts were replaced.No further issues have been reported.Note: ifu electromagnetic (em) ent head frame kit p/n 9733545 pg 6 contains contraindications and warnings regarding use of the head frame: contraindications.The em ent head frame is not recommended for: patients with circulatory diseases whose skin may be prone to damage from pressure from the silicone pads.Patients with topical treatments or oils that cannot/should not be removed.Unusual soft tissue sensitivity or damaged tissue at or near the intended mounting areas.Warnings: warning: always screen the patient for adverse reaction to all patient contacting materials, especially adhesives, prior to the procedure.Warning: do not mount the em ent head frame to irritated or wounded skin; skin reaction may occur.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation s7 system and non-invasive patient tracker.There is no allegation to suggest that medtronic navigation's devices caused or contributed to the reported event.

Event Description

A medtronic ent representative received a report that, following an ear, nose & throat (ent) procedure, the patient displayed a skin abrasion under the non-invasive patient tracker.When the patient tracker was removed, the adhesive had left an abrasion on the patient's forehead.It appeared the adhesive had broken the skin and caused some very minor bleeding.It was observed that the patient may have had a sun burn prior to surgery, the patient's face was red all over.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.Surgeon was not concerned about the medtronic products, or felt the medtronic products were at fault.The surgeon treated the abrasion with bacitracin and there were no further issues.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation s7 system and non-invasive patient tracker.

• Brand Name: STEALTHSTATION S7 SYSTEM
• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 5745195
• MDR Text Key: 48039208
• Report Number: 1723170-2016-01161
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• 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
• Report Date: 06/23/2016

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?: No
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2014
• 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: PATIENT TRACKER 9734887XOM NON-INVASIVE
• Patient Outcome(s): Required Intervention