BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7167007 · Received January 5, 2018

    Report

    Report Number
    2951250-2018-00177
    Event Type
    Injury
    Date Received
    January 5, 2018
    Report Date
    April 8, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SHARP AND STABBING PELVIC PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "NOVASURE ABLATION AND ESSURE" IN 2012 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT HAVE ESSURE CONFIRMATION TEST FOLLOWING PLACEMENT". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 ((B)(6) 2003, (B)(6) 2005), C-SECTION, PRE-ECLAMPSIA, CONGESTIVE HEART FAILURE, FIBROIDS, UTERINE BLEEDING AND ADENOMYOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA AND MIRENA FROM 2010 TO 2012. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED ANALGESICS. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE AND PERSISTENT ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), LOSS OF LIBIDO ("NO SEX DRIVE"), MIGRAINE ("MIGRAINES/SEVERE MIGRAINE"), ASTHENIA ("LITTLE TO NO ENERGY"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL TENDERNESS ("TENDER ABDOMEN"), IRRITABILITY ("EXTREMELY IRRITABLE"), INSOMNIA ("INSOMNIA") AND NAUSEA ("SEVERE NAUSEA") AND WAS FOUND TO HAVE HEART RATE INCREASED ("RAPID HEART BEAT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("ALL OVER BODY ACHES \ PAIN"), BACK PAIN ("BACK PAIN"), HYPERSENSITIVITY ("HYPERSENSITIVITY") WITH RASH, HYPOAESTHESIA ("NUMBNESS OF HANDS & FEET"), MENTAL DISORDER ("PSYCHOLOGICAL CONDITION") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC LAPAROSCOPIC TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY). ESSURE WAS REMOVED ON 14(B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, LOSS OF LIBIDO, MIGRAINE, ASTHENIA, DYSPAREUNIA, ABDOMINAL TENDERNESS, IRRITABILITY, INSOMNIA, HEART RATE INCREASED, NAUSEA, PAIN, BACK PAIN, HYPERSENSITIVITY, HYPOAESTHESIA AND MENTAL DISORDER OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION AND HEADACHE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL TENDERNESS, ASTHENIA, AUTOIMMUNE DISORDER, BACK PAIN, DYSPAREUNIA, HEADACHE, HEART RATE INCREASED, HYPERSENSITIVITY, HYPOAESTHESIA, INSOMNIA, IRRITABILITY, LOSS OF LIBIDO, MENTAL DISORDER, MIGRAINE, NAUSEA, PAIN AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.7 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2019: MEDICAL RECORDS RECEIVED. EVENT PER MR: ABLATION PERFORMED CONCOMITANTLY WITH ESSURE INSERT WAS ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SHARP AND STABBING PELVIC PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "NOVASURE ABLATION AND ESSURE" IN 2012 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT HAVE ESSURE CONFIRMATION TEST FOLLOWING PLACEMENT". THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 ((B)(6) 2003,(B)(6) 2005), C-SECTION, PRE-ECLAMPSIA, CONGESTIVE HEART FAILURE, FIBROIDS, UTERINE BLEEDING AND ADENOMYOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA AND MIRENA FROM 2010 TO 2012. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED ANALGESICS. IN DECEMBER 2012, THE PATIENT HAD ESSURE INSERTED. IN JANUARY 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE AND PERSISTENT ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), LOSS OF LIBIDO ("NO SEX DRIVE"), MIGRAINE ("MIGRAINES/SEVERE MIGRAINE"), ASTHENIA ("LITTLE TO NO ENERGY"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL TENDERNESS ("TENDER ABDOMEN"), IRRITABILITY ("EXTREMELY IRRITABLE"), INSOMNIA ("INSOMNIA") AND NAUSEA ("SEVERE NAUSEA") AND WAS FOUND TO HAVE HEART RATE INCREASED ("RAPID HEART BEAT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("ALL OVER BODY ACHES \ PAIN"), BACK PAIN ("BACK PAIN"), HYPERSENSITIVITY ("HYPERSENSITIVITY") WITH RASH, HYPOAESTHESIA ("NUMBNESS OF HANDS & FEET"), MENTAL DISORDER ("PSYCHOLOGICAL CONDITION") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC LAPAROSCOPIC TOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, LOSS OF LIBIDO, MIGRAINE, ASTHENIA, DYSPAREUNIA, ABDOMINAL TENDERNESS, IRRITABILITY, INSOMNIA, HEART RATE INCREASED, NAUSEA, PAIN, BACK PAIN, HYPERSENSITIVITY, HYPOAESTHESIA AND MENTAL DISORDER OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION AND HEADACHE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL TENDERNESS, ASTHENIA, AUTOIMMUNE DISORDER, BACK PAIN, DYSPAREUNIA, HEADACHE, HEART RATE INCREASED, HYPERSENSITIVITY, HYPOAESTHESIA, INSOMNIA, IRRITABILITY, LOSS OF LIBIDO, MENTAL DISORDER, MIGRAINE, NAUSEA, PAIN AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.7 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: UPON RECEIPT OF A NEW FOLLOW-UP INFORMATION, CASE 2018-078279 WAS IDENTIFIED AS DUPLICATE. ALL REFERENCES AND INFORMATION FROM DELETED DUPLICATE CASE WERE TRANSFERRED TO THIS CASE. REPORTER'S INFORMATION WAS UPDATED AND A NEW REPORTER WAS ADDED, AND PATIENT'S INITIALS WAS UPDATED. INCIDENT NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, 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 ("SHARP AND STABBING PELVIC PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") IN AN ADULT PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT HAVE ESSURE CONFIRMATION TEST FOLLOWING PLACEMENT". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 ((B)(6) 2003, (B)(6) 2005), C-SECTION, PRE-ECLAMPSIA AND CONGESTIVE HEART FAILURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA IN (B)(6) 2012 AND MIRENA FROM 2010 TO 2012. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED ANALGESICS. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE AND PERSISTENT ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), LOSS OF LIBIDO ("NO SEX DRIVE"), MIGRAINE ("MIGRAINES/SEVERE MIGRAINE"), ASTHENIA ("LITTLE TO NO ENERGY"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL TENDERNESS ("TENDER ABDOMEN"), IRRITABILITY ("EXTREMELY IRRITABLE"), INSOMNIA ("INSOMNIA"), HEART RATE INCREASED ("RAPID HEART BEAT"), NAUSEA ("SEVERE NAUSEA"), PAIN ("ALL OVER BODY ACHES \ PAIN"), BACK PAIN ("BACK PAIN"), HYPERSENSITIVITY ("HYPERSENSITIVITY") WITH RASH, HYPOAESTHESIA ("NUMBNESS OF HANDS & FEET"), MENTAL DISORDER ("PSYCHOLOGICAL CONDITION") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, LOSS OF LIBIDO, MIGRAINE, ASTHENIA, DYSPAREUNIA, ABDOMINAL TENDERNESS, IRRITABILITY, INSOMNIA, HEART RATE INCREASED, NAUSEA, PAIN, BACK PAIN, HYPERSENSITIVITY, HYPOAESTHESIA AND MENTAL DISORDER OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL DISTENSION AND HEADACHE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL TENDERNESS, ASTHENIA, AUTOIMMUNE DISORDER, BACK PAIN, DYSPAREUNIA, HEADACHE, HEART RATE INCREASED, HYPERSENSITIVITY, HYPOAESTHESIA, INSOMNIA, IRRITABILITY, LOSS OF LIBIDO, MENTAL DISORDER, MIGRAINE, NAUSEA, PAIN AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11705 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R ANALGESICS| ANALGESICS| ANALGESICS| ANALGESICS