FDA Adverse Event Injury Summary report: N

AMERICAN SYSTEMS, INC. ELEVATE

MDR report key: 2240791 · Received September 3, 2011

Report

Report Number
MW5022137
Event Type
Injury
Date Received
September 3, 2011
Date of Event
June 15, 2011
Report Date
September 3, 2011
Manufacturer
AMERICAN MEDICAL SYSTEMS, INC.
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2011, GYNECOLOGIST (B)(6), MD., DIAGNOSED UTERINE PROCIDENTIA (PLEASE NOTE: BEYOND STAGE 3-ORGAN FULLY EXTERIOR TO BODY) CYSTOCELE, RECTOCELE, MAL-ODOROUS VAGINAL DISCHARGE. PERFORMED POP A/P REPAIRS SURGERY WITH IMPLANTATION OF ANTERIOR AND POSTERIOR TRANSVAGINAL MESH USING AMS ELEVATE KIT WITH 2 DAYS IN-PT HOSPITAL STAY AT (B)(6). POST-OP: EXTREME URINARY INCONTINENCE IMMEDIATELY UPON STANDING-NOT ¿USI¿ (NO PREVIOUS INCONTINENCE OF ANY KIND PRIOR TO MESH) PAIN, EXCESSIVE VAGINAL BLEEDING FOR 2 WEEKS, FECAL INCONTINENCE. (B)(6) HEALTH HOSPITALIZATION OUT PATIENT. MRI FOUND 8 CM X 8 CM HEMATOMA IN VAGINAL/RECTAL SPACE, SECOND SURGERY (EMERGENCY) SAME HOSPITAL/SURGEON OR HEMATOMA DRAIN AND CYSTOSCOPY. POST-SECOND OP: UNREMITTING, EXCESSIVE VAGINAL BLEEDING, PAIN, BLADDER INFECTION. ON (B)(6) 2011, POST-OP EXAM WITH DR (B)(6). DIAGNOSIS: MESH EROSION INTO VAGINA. ON (B)(6) 2011, ANNUAL PHYSICAL WITH REGULAR INTERNIST (INCLUDES URINALYSIS) FOUND WB CELLS, RB CELLS AND OCCULT BLOOD IN URINE, REFERRED TO MEDICAL DIRECTOR UROGYNECOLOGY, (B)(6). (B)(6). AFTER VAGINAL EXAMINATION, BLADDER/URINE TESTS AND PELVIC SONOGRAM, DR (B)(6)¿S DIAGNOSIS: ALL 3 ORGANS ONCE AGAIN PROLAPSED, UTERUS-STAGE 3, BLADDER STAGE 2, RECTUM STAGE 2, FOUND MESH INSIDE OF ¿UNHEALED VAGINAL INCISION¿, MESH COMPRESSION ON RECTUM, RECOMMENDED THE REMOVAL OF ALL MESH POSSIBLE TO EXTRACT. ¿MESH HAS ALREADY INTEGRATED WITH TISSUE, IMPOSSIBLE TO REMOVE ALL MESH W/O SIGNIFICANT DAMAGE TO PT¿S VITAL ORGANS.¿ SIGNIFICANT DIFFICULTY, DAILY, IN EVACUATION OF BOWELS ALTHOUGH TAKING 100 MG STOOL SOFTENER DAILY, SINCE (B)(6) 2011. CURRENT VAGINAL DISCHARGE/BLEEDING REQUIRES DAILY USE OF PADS, ON-GOING SHARP STABBING-LIKE PELVIC PAIN ATTRIBUTED TO MESH EROSION. CONTINUED FULL TIME AND HIGHLY MEANINGFUL/TREASURED EMPLOYMENT IN PUBLIC MIDDLE SCHOOL INSTRUCTION OF SPECIAL ED. STUDENTS FOR LAST 18 YEARS IS NOW AT RISK. PHYSICAL LIMITATIONS, AS A RESULT OF MESH SURGERIES HAVE COMPROMISED MY ABILITY TO PERFORM THE RESPONSIBILITIES/DUTIES OF MY JOB. IN ADDITION TO PHYSICAL PAIN, I AM ALSO EXPERIENCING PSYCHOLOGICAL DISTRESS. AS THE SOLE INCOME EARNER OF MY HOUSEHOLD (I LIVE ALONE) THE DAMAGES DONE TO MY PHYSICAL CONDITION, THAT ARE A DIRECT RESULT OF THE ABOVE DETAILED SURGICAL PROCEDURES, POSE A THREAT TO MY ABILITY TO CONTINUE TO PRODUCE INCOME, MAINTAIN MEDICAL INSURANCE THROUGH MY EMPLOYER AND MY PROVIDE FOR MY FUTURE FINANCIAL, AS WELL AS PHYSICAL, WELLBEING AND SECURITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AMERICAN SYSTEMS, INC. ELEVATE MESH SLING FEMALE ANTERIOR AND POSTERIOR "ELEVATE" FTL AMERICAN MEDICAL SYSTEMS, INC. UNK 712379008
2 AMERICAN SYSTEMS, INC., ELEVATE MESH SLING FEMALE ANTERIOR AND POSTERIOR "ELEVATE" FTL AMERICAN MEDICAL SYSTEMS, INC. UNK 712423010

Patients

Seq Age Sex Outcome Treatment
1 63 YR Hospitalization| O| S