MAUDE MDR 4945901

MDR report key
4945901
Report number
1721293-2015-00004
Event key
0
Event type
3
Date of event
2015-06-30
Date received
2015-07-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. DEBBIE MIRANDA
Address
205 HWY 22 EAST CLEAR LAKE SD 57226 US
Phone
605-605-6058
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CONTINUUMCONTINUUMEMPI, INCIPF199610-001N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-2801. H

Event Narratives#

D

Patient 1

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.

N

Patient 1

A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.