MAUDE Adverse Event Report: EMPI, INC CONTINUUM

Model Number 199610-001

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Headache (1880)

Event Date 06/30/2015

Event Type  Injury  

Event Description

It was reported that a patient was admitted to the emergency room for chest pains while using an empi device.On (b)(6) 2015 the patient stated that she was using an nmes device on her right hip.She has been using this device for several weeks.15 minutes into the treatment she felt an intense pain in the left side of her chest, back and shoulder area.The patient then went to the er, where an ekg was done at the time she was admitted and again four hours later.She also had a chest x-ray, and blood work.The er doctor stated to the patient that she passed the initial test.The er doctor said that the final interpretation of the x-ray and blood test would be in 48-72 hours.The er doctor suggested to discontinue using the device and to follow-up with her primary physician and suggested a stress test.The patient said she still feels lightheaded and short of breath.On (b)(6) 2015 the patient seen her primary physician, her physician stated that she was puzzled on why she had this experience.The patient has no known cardiac issues previous to this event and that the patient will continue to use the device.

Manufacturer Narrative

A follow-up report will be submitted once the evaluation is completed.

• Brand Name: CONTINUUM
• Type of Device: CONTINUUM
• Manufacturer (Section D): EMPI, INC; 205 hwy 22 east; clear lake SD 57226
• Manufacturer (Section G): EMPI, INC; 205 hwy 22 east; clear lake SD 57226
• Manufacturer Contact: debbie miranda ; 205 hwy 22 east; clear lake, SD 57226 ; 6058747057
• MDR Report Key: 4945901
• MDR Text Key: 16497876
• Report Number: 1721293-2015-00004
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• PMA/PMN Number: K093324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 199610-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2013
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization