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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL 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 Key5745195
MDR Text Key48039208
Report Number1723170-2016-01161
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
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
Date FDA Received06/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/02/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/23/2016 Patient Sequence Number: 1
Treatment
PATIENT TRACKER 9734887XOM NON-INVASIVE
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