MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® 2.0 INTERFACE; ELECTROMYOGRAPH, DIAGNOSTIC

Model Number 8252200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis.Pre-repair inspection confirmed the reported event of no stimulation response and found a broken cable.Device evaluation not yet complete, completion of evaluation anticipated.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that before the procedure there was no stimulation response from the device.There was no patient impact.

Manufacturer Narrative

Device evaluation has been completed.Analysis confirmed the reported event of no stimulation response.The device was not repaired.The customer replaced their device with a new device.

Event Description

Additional information received indicated that the nerve location known, but the device was not detecting it.The system did not alert the user of the issue.When going from the set-up to the monitoring screen the device was recognizing the electrodes.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® 2.0 INTERFACE
• Type of Device: ELECTROMYOGRAPH, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: sharanya jangiti ; 6743 southpoint dr n; jacksonville, FL 32216 ; 9043328183
• MDR Report Key: 6266408
• MDR Text Key: 65384080
• Report Number: 1045254-2017-00033
• Device Sequence Number: 1
• Product Code: IKN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K024316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8252200
• Device Catalogue Number: 8252200
• Device Lot Number: 60601100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 70