MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-07-28 for CONTINUUM 199610-001 manufactured by Empi, Inc.
[16497876]
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.
Patient Sequence No: 1, Text Type: D, B5
[16792348]
A follow-up report will be submitted once the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2015-00004 |
| MDR Report Key | 4945901 |
| Report Source | 04 |
| Date Received | 2015-07-28 |
| Date of Report | 2015-07-01 |
| Date of Event | 2015-06-30 |
| Date Mfgr Received | 2015-07-01 |
| Device Manufacturer Date | 2013-05-28 |
| Date Added to Maude | 2015-07-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DEBBIE MIRANDA |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal | 57226 |
| Manufacturer Phone | 6058747057 |
| Manufacturer G1 | EMPI, INC |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTINUUM |
| Generic Name | CONTINUUM |
| Product Code | IPF |
| Date Received | 2015-07-28 |
| Model Number | 199610-001 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI, INC |
| Manufacturer Address | 205 HWY 22 EAST CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-07-28 |