MAUDE Adverse Event Report: MEDTRONIC XOMED INC.ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RESTIMULATOR, NERVE

Model Number 8229307

Device Problem Collapse

Event Date 04/13/2011

Event Type  Malfunction  

Manufacturer Narrative

Event Description

(b)(4). The customer was able to supply the lot number 66466400.

Manufacturer Narrative

The customer reported filing medwatch (b)(4) to the fda. A review of the fda maude database did not show this product complaint being received, neither has the medwatch been received by xomed as of this date. This product was being used for treatment and not for diagnoses.

Event Description

Description of the original complaint: shortly after the anesthesiologist intubated the patient started to destat and there was a question as to whether the tube was properly functioning. The tube was then replaced with a non- laryngeal nerve monitoring endotracheal tube with no problems with air movement, or ventilation. Relevant events and information obtained for the reported case: the patient was discharged after 1 day post op. Without further comp lications. The patient had no reported pre-existing airway/respiratory conditions. The product disposed of the emg tube after the procedure. The customer reported a similar occurrence with the xomed emg tube which is to be filed as a separate 3500a incident.

• Brand Name: ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE
• Type of Device: STIMULATOR, NERVE
• Manufacturer (Section F): MEDTRONIC XOMED INC.; 6743 southpoint dr. n.; jacksonville FL 32216
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr. n.; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: mr. mike mosby ; 6743 southpoint drive north; jacksonville , FL 32216; (904) 279 -7584
• Device Event Key: 2125593
• MDR Report Key: 2096866
• Event Key: 1993842
• Report Number: 2096866
• Device Sequence Number: 1
• Product Code: ETN
• Report Source: Manufacturer
• Source Type: Health Professional,User facility
• Reporter Occupation: RISK MANAGER
• Type of Report: Initial,Followup
• Report Date: 04/26/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 05/20/2011
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device EXPIRATION Date: 02/23/2014
• Device MODEL Number: 8229307
• Device Catalogue Number: 8229307
• Device LOT Number: 66466400
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 04/26/2011
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/07/2010
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Initial