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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. NIM EMG ENDOTRACHEAL TUBE WITH PROTECTED LEAD MONITORING DISPOSABLE

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MEDTRONIC XOMED, INC. NIM EMG ENDOTRACHEAL TUBE WITH PROTECTED LEAD MONITORING DISPOSABLE Back to Search Results
Model Number 8229306
Device Problem Electrode(s), migration of
Event Date 07/22/2004
Event Type  Malfunction  
Event Description

Reporter reported that the electrodes went out of their sheath. One product returned, per customer information: no vigilance report sent to the afssaps - no serious injury for the patient. Customer returned product without lot number or any other identifying information.

 
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Brand NameNIM EMG ENDOTRACHEAL TUBE WITH PROTECTED LEAD
Type of DeviceMONITORING DISPOSABLE
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
6743 southpoint dr. n.
jacksonville FL 32216
Manufacturer Contact
bill wiggins
6743 southpoint drive north
jacksonville , FL 32216
(904) 332 -8196
Device Event Key868428
MDR Report Key891134
Event Key853486
Report Number1045254-2004-00007
Device Sequence Number1
Product CodeBTR
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation NO INFORMATION
Remedial Action Inspection
Type of Report Initial
Report Date 09/30/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/13/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number8229306
Device Catalogue Number8229306
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/29/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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? No Answer Provided
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/13/2004 Patient Sequence Number: 1
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