BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8926300 · Received August 23, 2019

    Report

    Report Number
    2951250-2019-05050
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A HEALTH PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2019, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADENOMYOSIS ("ADENOMYOSIS"), ARTHRALGIA ("ARTHRALGIA"), MYALGIA ("MYALGIA"), INSOMNIA ("INSOMNIA"), MEMORY IMPAIRMENT ("MEMORY DISORDERS") AND PYREXIA ("FEVER"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, ADENOMYOSIS, ARTHRALGIA, MYALGIA, INSOMNIA, MEMORY IMPAIRMENT AND PYREXIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ADENOMYOSIS, ARTHRALGIA, INSOMNIA, MEDICAL DEVICE REMOVAL, MEMORY IMPAIRMENT, MYALGIA AND PYREXIA WITH ESSURE. THE REPORTER COMMENTED: REPORTER CONFIRMED THAT THE DEFECTIVE DEVICE IS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-AUG-2019: THE CASE WILL BE DELETED FROM BAYER PV DATABASE. NULLIFICATION REASON: AS PER INFORMATION RECEIVED, THIS CASE WAS IDENTIFIED AS A DUPLICATE OF CASE 2019-082826. ALL THE INFORMATION FROM CASE 2019-155720 HAS BEEN TRANSFERRED TO CASE 2019-082826. 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 THEIR 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 HEALTH PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2019, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADENOMYOSIS ("ADENOMYOSIS"), ARTHRALGIA ("ARTHRALGIA"), MYALGIA ("MYALGIA"), INSOMNIA ("INSOMNIA"), MEMORY IMPAIRMENT ("MEMORY DISORDERS") AND PYREXIA ("FEVER"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, ADENOMYOSIS, ARTHRALGIA, MYALGIA, INSOMNIA, MEMORY IMPAIRMENT AND PYREXIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ADENOMYOSIS, ARTHRALGIA, INSOMNIA, MEDICAL DEVICE REMOVAL, MEMORY IMPAIRMENT, MYALGIA AND PYREXIA WITH ESSURE. THE REPORTER COMMENTED: REPORTER CONFIRMED THAT THE DEFECTIVE DEVICE IS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: A NEW LETTER WAS SENT AND TO REPLACE PREVIOUS ONE. EVENTS ASTHENIA, DEPRESSION, DENTAL SYMPTOMS WERE DELETED AND EVENT FEVER WAS ADDED. REPORTER CONFIRMED THAT THE DEFECTIVE DEVICE IS AVAILABLE. 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 THEIR NON-CONFORMANCE'S 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 HEALTH PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADENOMYOSIS ("ADENOMYOSIS"), ARTHRALGIA ("ARTHRALGIA"), MYALGIA ("MYALGIA"), ASTHENIA ("ASTHENIA"), INSOMNIA ("INSOMNIA"), MEMORY IMPAIRMENT ("MEMORY DISORDERS"), DEPRESSION ("DEPRESSION") AND TOOTH DISORDER ("DENTAL SYMPTOMS"). ON (B)(6) 2019, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). AT THE TIME OF THE REPORT, THE ADENOMYOSIS, ARTHRALGIA, MYALGIA, ASTHENIA, INSOMNIA, MEMORY IMPAIRMENT, DEPRESSION AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ADENOMYOSIS, ARTHRALGIA, ASTHENIA, DEPRESSION, INSOMNIA, MEDICAL DEVICE REMOVAL, MEMORY IMPAIRMENT, MYALGIA AND TOOTH DISORDER WITH ESSURE. 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 THEIR NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719148 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R