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

Model Number 8229306

Device Problem Electrode(s), migration of

Event Date 07/22/2004

Event Type  Malfunction   Patient Outcome  Other

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.

• Brand Name: NIM EMG ENDOTRACHEAL TUBE WITH PROTECTED LEAD
• Type of Device: MONITORING 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 Key: 868428
• MDR Report Key: 891134
• Event Key: 853486
• Report Number: 1045254-2004-00007
• Device Sequence Number: 1
• Product Code: BTR
• 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 Received: 10/13/2004
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device MODEL Number: 8229306
• Device Catalogue Number: 8229306
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2004
• 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

#	Treatment	Treatment Date
NI