MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. NIM CONTACT; STIMULATOR, NERVE

Model Number 8229508

Device Problems Detachment Of Device Component (1104); Inflation Problem (1310); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2017

Event Type  malfunction  

Event Description

Patient was brought to the operating room and readied for intubation.Patient was intubated by doctor using the nim contact emg endotracheal tube (ett) size 8 without problem.When the doctor went to inflate the ett cuff, the inflation tubing came off in his hand and he was unable to inflate the cuff.The doctor then utilized an introducer (bougie) and removed the defective ett, and replaced it with another nim contact emg ett size 8.The cuff was easily inflated and the case proceeded without further problem.

• Brand Name: NIM CONTACT
• Type of Device: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint dr. north; jax FL 32216
• MDR Report Key: 7107922
• MDR Text Key: 94504621
• Report Number: 7107922
• Device Sequence Number: 1
• Product Code: BXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/25/2019
• Device Model Number: 8229508
• Device Catalogue Number: 8229508
• Device Lot Number: 0210050657
• Other Device ID Number: M000030B585 A 0079
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR