MAUDE MDR 8297097

MDR report key
8297097
Report number
MW5083628
Event key
0
Event type
3
Date of event
2017-12-01
Date received
2019-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ESOPHYX DEVICEENDOSCOPIC SUTURE/PLICATION SYSTEM GASTROESOPHAGEAL REFLUX DISEASE (GERD)ENDOGASTRIC SOLUTIONS, INC.ODEI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-3101. S

Event Narratives#

D

Patient 1

DR. (B)(6) PERFORMED THE TIF TRANSORAL INCISIONLESS FUNDOPLICATION PROCEDURE USING THE ESOPHYX DEVICE. THE DEVICE ESOPHYX GOT LODGED IN MY ESOPHAGUS CAUSING A LARGE HOLE AND TEAR. THE RETRACTORS WOULD NOT RETRACT BACK IN AND IT TORE MY ESOPHAGUS. THAT CAUSED ME TO HAVE A METAL STENT WRAPPED AROUND MY ESOPHAGUS FOR A PAINFUL 6 WEEKS. I HAD REACTIONS TO MANY MEDICATIONS WHICH CAUSED NAUSEA AND NO APPETITE. I LOST ALL MY MUSCLE MASS AND COULD NOT WALK. I WAS BED RIDDEN FOR 5 STRAIGHT MONTHS LEARNING TO WALK AGAIN. I WENT INTO A DEPRESSION FOR THE FIRST TIME IN MY LIFE. I LOST 15 POUNDS. MY DIET HAS CHANGED. I AM LEFT WITH ESOPHAGEAL SPASMS THAT CONSTANTLY NEVER STOP. I HAVE WEAK VOCAL CORDS AND MY VOICE HAS CHANGED. I HAVE LIQUID GOING DOWN THE WRONG WINDPIPE CAUSING COUGHING. I HAVE NARROWING OF THE ESOPHAGUS THAT THE DOCTOR SAYS HE CAN OPEN AS FREQUENTLY AS NEEDED BY PERFORMING AN ESOPHAGEAL SCOPE GOING INTO ESOPHAGUS. THAT REQUIRES ANESTHESIA WHICH IS RISKY. I HAVE DISCOMFORT AND PAIN IN ESOPHAGUS DAILY ALL DAY AND SLEEP STRAIGHT UP FOR OVER A YEAR. THAT HAS LED TO CHRONIC BACK PAIN AND DISC ISSUES. I HAD 2 GASTROPARESIS ATTACKS THAT ONE WAS HOSPITALIZED. CONSTIPATION AS WELL AT TIMES. I AM WORSE OFF THAN BEFORE THE SURGERY TO REPAIR A SMALL HIATAL HERNIA. I STILL NOW HAVE TO TAKE THE NEXIUM WHICH MY DOCTOR BELIEVES AFTER 12 YEARS HAS CAUSED ME TO BE DIAGNOSED WITH OSTEOPENIA. I HAD TAKEN A MEDICATION IN THE NITRO FAMILY THAT SIDE EFFECTS ARE COPD. I NOW HAVE BEEN DIAGNOSED WITH COPD AND HAVE BREATHING PROBLEMS AND EXTREME FATIGUE. I LOST MY MEDICAL BILLING COMPANY OF 12 YEARS DUE TO LACK OF BEING ABLE TO WORK.