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U.S. Department of Health and Human Services

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

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MEDTRONIC XOMED INC. ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE STIMULATOR, NERVE Back to Search Results
Model Number 8229307
Device Problem Collapse
Event Date 04/13/2011
Event Type  Malfunction  
Event Description

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

 
Manufacturer Narrative

 
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.

 
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Brand NameENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE
Type of DeviceSTIMULATOR, 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 Key2125593
MDR Report Key2096866
Event Key1993842
Report Number2096866
Device Sequence Number1
Product CodeETN
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 Received05/20/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/23/2014
Device MODEL Number8229307
Device Catalogue Number8229307
Device LOT Number66466400
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received04/26/2011
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/07/2010
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

Patient TREATMENT DATA
Date Received: 05/20/2011 Patient Sequence Number: 1
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