BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8600138 · Received May 10, 2019

    Report

    Report Number
    2951250-2019-01854
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    September 1, 2017
    Report Date
    November 12, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B66017) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT DONE". THE PATIENT'S MEDICAL HISTORY INCLUDED COLONOSCOPY IN 2002, GASTRIC DISORDER IN 2001, GASTRIC BYPASS IN 2001, FEVER, HYPOTHYROIDISM, ANEMIA, GENITAL BLEEDING, MULTIGRAVIDA, PARITY 3, ABORTION, INFECTION, ABDOMINAL OPERATION, MUSCLE CRAMPS, INFLAMMATION, UTERINE PROLAPSE AND OVARIAN STROMAL HYPERPLASIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA FROM 2007 TO 5-FEB-2014. CONCURRENT CONDITIONS INCLUDED ANEMIA, INFLUENZA, MEASLES, VERTIGO, ENDOMETRIAL ABLATION, NICKEL SENSITIVITY, BACK PAIN, CYSTOCELE, RECTOCELE, CERVICITIS, ENDOMETRIUM CYSTIC, CYST, FIBROSIS, VAGINAL DISORDER, HYPERMOBILITY SYNDROME, PELVIC DISCOMFORT AND STRESS URINARY INCONTINENCE. CONCOMITANT PRODUCTS INCLUDED BLOOD TRANSFUSION, AUXILIARY PRODUCTS, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), LEVOFLOXACIN (LEVAQUIN), LEVONORGESTREL (MIRENA) AND LEVOTHYROXINE SODIUM. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN JUNE 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN JANUARY 2015, THE PATIENT EXPERIENCED RASH ("LEG RASHES/ RASH ON LOWER LEGS") AND DENTAL CARIES ("CAVITIES") AND UNDERWENT TOOTH EXTRACTION ("TOOTH EXTRACTION"). IN 2015, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN JANUARY 2017, THE PATIENT EXPERIENCED BARRETT'S OESOPHAGUS ("BARRETT'S ESOPHAGUS"), ANAEMIA ("ANEMIA"), DIZZINESS ("DIZZINESS") AND EAR DISORDER ("EAR PROBLEMS") AND WAS FOUND TO HAVE BLOOD POTASSIUM DECREASED ("LOW POTASSIUM"). IN SEPTEMBER 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE") AND MUSCLE SPASMS ("SEVERE MUSCULAR CRAMPS ALL OVER BODY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN ("ALL OVER THE BODY PAIN"), INFLAMMATION ("INFLAMMATION"), ABDOMINAL PAIN LOWER ("CRAMPING") AND VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, POTASSIUM, PSEUDOEPHEDRINE HYDROCHLORIDE, STEROIDS AND SURGERY (BILATERAL SALPINGO-OOPHORECTOMY, VAGINAL HYSTERECTOMY,ANTERIOR & POSTERIOR COLPOPERINEOPLASTY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, TOOTH DISORDER, FATIGUE, BARRETT'S OESOPHAGUS, BLOOD POTASSIUM DECREASED, ANAEMIA, DIZZINESS, EAR DISORDER, DENTAL CARIES, TOOTH EXTRACTION AND VITAMIN D DEFICIENCY OUTCOME WAS UNKNOWN AND THE RASH, DYSMENORRHOEA, MUSCLE SPASMS, PAIN, INFLAMMATION AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANAEMIA, BARRETT'S OESOPHAGUS, BLOOD POTASSIUM DECREASED, DENTAL CARIES, DIZZINESS, DYSMENORRHOEA, EAR DISORDER, FATIGUE, INFLAMMATION, MUSCLE SPASMS, PAIN, PELVIC PAIN, RASH, TOOTH DISORDER, TOOTH EXTRACTION AND VITAMIN D DEFICIENCY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE IMPLANT DATE JAN-2014 AND (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.5 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-OCT-2019: PFS RECEIVED- NEW EVENTS VITAMIN D DEFICIENCY WERE ADDED. OUTCOME OF MUSCLE SPASMS, DYSMENORRHOEA UPDATED TO RECOVERED / RESOLVED. TREATMENT DRUG WERE ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B66017) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT DONE". THE PATIENT'S MEDICAL HISTORY INCLUDED FEVER, GASTRIC DISORDER IN 2001, GASTRIC BYPASS IN 2001, COLONOSCOPY IN 2002, HYPOTHYROIDISM, ANEMIA, GENITAL BLEEDING, MULTIGRAVIDA, PARITY 3, ABORTION, INFECTION, ABDOMINAL OPERATION, MUSCLE CRAMPS, INFLAMMATION, UTERINE PROLAPSE AND OVARIAN STROMAL HYPERPLASIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA FROM 2007 TO (B)(6) 2014. CONCURRENT CONDITIONS INCLUDED ANEMIA, INFLUENZA, MEASLES, VERTIGO, ENDOMETRIAL ABLATION, NICKEL SENSITIVITY, BACK PAIN, CYSTOCELE, RECTOCELE, CERVICITIS, ENDOMETRIUM CYSTIC, CYST, FIBROSIS, VAGINAL DISORDER, HYPERMOBILITY SYNDROME, PELVIC DISCOMFORT AND STRESS URINARY INCONTINENCE. CONCOMITANT PRODUCTS INCLUDED BLOOD TRANSFUSION, AUXILIARY PRODUCTS, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), LEVOFLOXACIN (LEVAQUIN), LEVONORGESTREL (MIRENA) AND LEVOTHYROXINE SODIUM. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2015, THE PATIENT EXPERIENCED RASH ("LEG RASHES/ RASH ON LOWER LEGS"), TOOTH DISORDER ("DENTAL PROBLEMS") AND DENTAL CARIES ("CAVITIES") AND UNDERWENT TOOTH EXTRACTION ("TOOTH EXTRACTION"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS") AND EAR DISORDER ("EAR PROBLEMS"). IN (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE BLOOD POTASSIUM DECREASED ("LOW POTASSIUM") AND EXPERIENCED ANAEMIA ("ANEMIA"). IN 2017, THE PATIENT EXPERIENCED BARRETT'S OESOPHAGUS ("BARRETT'S ESOPHAGUS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE") AND MUSCLE SPASMS ("SEVERE MUSCULAR CRAMPS ALL OVER BODY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN ("ALL OVER THE BODY PAIN"), INFLAMMATION ("INFLAMMATION") AND ABDOMINAL PAIN LOWER ("CRAMPING"). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, TOOTH DISORDER, DYSMENORRHOEA, FATIGUE, BARRETT'S OESOPHAGUS, MUSCLE SPASMS, BLOOD POTASSIUM DECREASED, ANAEMIA, DIZZINESS, EAR DISORDER, DENTAL CARIES AND TOOTH EXTRACTION OUTCOME WAS UNKNOWN AND THE RASH, PAIN, INFLAMMATION AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANAEMIA, BARRETT'S OESOPHAGUS, BLOOD POTASSIUM DECREASED, DENTAL CARIES, DIZZINESS, DYSMENORRHOEA, EAR DISORDER, FATIGUE, INFLAMMATION, MUSCLE SPASMS, PAIN, PELVIC PAIN, RASH, TOOTH DISORDER AND TOOTH EXTRACTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE IMPLANT DATE (B)(6) 2014 AND (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.5 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-MAY-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORDS WERE RECEIVED. EVENTS PER PFS: PAIN, LEG RASHES/ RASH ON LOWER LEGS, DENTAL PROBLEMS, DYSMENORRHEA (CRAMPING), FATIGUE, BARRETT'S ESOPHAGUS, SEVERE MUSCULAR CRAMPS ALL OVER BODY, LOW POTASSIUM, ANEMIA, DIZZINESS, EAR PROBLEMS, CAVITIES, TOOTH EXTRACTION, ESSURE CONFIRMATION TEST NOT DONE, ALL OVER THE BODY PAIN, INFLAMMATION AND CRAMPING. CONCURRENT CONDITION, HISTORICAL DRUG, CONCOMITANT MEDICATION, LABORATORY DATE AND LOT NUMBER WERE ADDED. WE RECEIVED THE LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394206 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 B66017 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R BLOOD TRANSFUSION, AUXILIARY PRODUCTS| BLOOD TRANSFUSION, AUXILIARY PRODUCTS| LEVAQUIN| LEVAQUIN| LEVOTHYROXINE SODIUM| LEVOTHYROXINE SODIUM| MIRENA| MIRENA| NORCO| NORCO| BLOOD TRANSFUSION, AUXILIARY PRODUCTS| LEVAQUIN| LEVOTHYROXINE SODIUM| MIRENA| NORCO