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

Catalog Number 9732500

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

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

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information was refused to be provided by the surgeon.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Suspect adhesive pad has not returned to manufacturer for evaluation, return not expected.No further relevant issues reported.The instructions for use that accompany the device contains warnings and contraindications regarding use of this instrument: "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." "warning: always screen the patient for adverse reaction to all patient contacting materials, especially adhesives, prior to the procedure." "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.".

Event Description

A medtronic representative received a report from the site that after a functional endoscopic sinus surgery (fess) the adhesive pad for head tracker instrument was potentially causing irritation of the patients skin.There was no reported delay to the procedure due to this issue.The surgeon had completed the procedure with the use of the navigation system when the issue was observed.There was no known impact on patient outcome.

Manufacturer Narrative

Device lot number and expiration date now provided.Device manufacturing date now provided.

• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 5358057
• MDR Text Key: 35620285
• Report Number: 1723170-2016-00026
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974187
• 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,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/22/2016
• Device Catalogue Number: 9732500
• Device Lot Number: 0209905208
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1