MAUDE Adverse Event Report: INVIVO CORPORATION INVIVO QUADTRODE MRI ECG ELECTRODES

Model Number 989803179031

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); Burn, Thermal (2530)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

The user reported that a patient experienced a burn or allergic reaction after an mri.It was reported that the patient had a soft tissue neck, cervical and thoracic spine scan for a total of approximately 60 minutes scanning time (15:38- 16:21 on (b)(6) 2016).It was reported that there was some delay prior to scan while blood gasses were monitored on the patient.The patient then reportedly left the mr to have a chest x-ray before returning to intensive therapy unit.The quadtrode pad was reportedly removed in intensive therapy unit between 5-5:30 pm and the charge nurse who removed the quadtrode pad did not notice any marks on the patient.There was a report by the nursing staff of marks at 5:30 am on (b)(6) 2016.It was also reported that the patient has a sensitive skin type and, in the user's opinion, this may be an allergic reaction but that is not yet confirmed.We are awaiting further information on the treatment of this reaction, if any.On 23-nov-2016, it was reported that the marks on the patient have significantly faded.The user reports that the box of quadtrode pads has been removed from circulation, but that it had already been opened and some had been used already without incident prior to being used on this patient.

Manufacturer Narrative

It was reported that the patient experienced an allergic reaction to the quadtrode electrode.The user was provided with information about the composition of the electrodes so that the patient can avoid those components in the future.

• Brand Name: INVIVO QUADTRODE MRI ECG ELECTRODES
• Type of Device: ELECTRODES
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: denyse murphy ; 12151 research parkway; suite 200; orlando, FL 32826
• MDR Report Key: 6134467
• MDR Text Key: 61443911
• Report Number: 1051786-2016-00017
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K955045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2018
• Device Model Number: 989803179031
• Device Lot Number: 60307-0442
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1