MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. MAINFRAME 8252001 NIM-RESPONSE 2.0; ELECTROMYOGRAPH, DIAGNOSTIC

Model Number 8252001

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2014

Event Type  malfunction  

Event Description

It was reported that they were not getting a response when attempting to stimulate the nerve with the nim response 2.0.They had their stim set to 1.0ma and threshold at 100ua.They tried lowering the threshold but this did not resolve the issue.Surgeon was aborting use of nim.There was no impact on patient outcome.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).The product has not been returned for analysis.No testing methods performed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAINFRAME 8252001 NIM-RESPONSE 2.0
• Type of Device: ELECTROMYOGRAPH, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 3688529
• MDR Text Key: 4298136
• Report Number: 1045254-2014-00064
• Device Sequence Number: 1
• Product Code: IKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8252001
• Device Catalogue Number: 8252001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1