BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 882742 · Received July 17, 2007

    Report

    Report Number
    2951250-2007-00006
    Event Type
    Other
    Date Received
    July 17, 2007
    Date of Event
    April 13, 2007
    Report Date
    February 14, 2017
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED TO A FIELD-BASED CONCEPTUS EMPLOYEE, A CASE OF PELVIC PAIN THAT ULTIMATELY LEAD TO REMOVAL OF AN ESSURE DEVICE FROM THE PATIENT IN 2007. A CONCEPTUS MEDICAL LIAISON CONTACTED THE PHYSICIAN WHO PERFORMED THE SURGERY. HE STATED, THAT HE DID NOT ORIGINALLY PLACE THE ESSURE MICRO-INSERTS; RATHER, THE PATIENT CAME TO HIM FOR A SECOND OPINION. THE PATIENT HAD THE ESSURE PROCEDURE IN 2004. THE 3 MONTH HSG POST ESSURE INDICATED A PERFORATION WITH ONE OF THE DEVICES LOCATED IN THE ABDOMINAL CAVITY. THE PHYSICIAN THAT ORIGINALLY PLACED THE DEVICES PERFORMED A BTL, BUT COULD ONLY LOCATE ONE DEVICE FOR REMOVAL. THE PATIENT HAS EXPERIENCED INTERMITTENT LLQ/ABDOMINAL PAIN FOR THE PAST TWO YEARS DURING WHICH TIME SHE HAS HAD A COUPLE OF CT SCANS AND AN MRI TO IDENTIFY A POSSIBLE CAUSE FOR THE PAIN. THE LATEST CT SCAN SHOWED THE REMAINING MICRO-INSERT TO BE WITHIN THE OMENTUM UP UNDER THE LEFT RIB CAGE. SHE LATER PRESENTED TO THE ER WITH SEVERE LLQ PAIN AND NAUSEA AND VOMITING. THE OPERATING PHYSICIAN (INITIAL REPORTER) PERFORMED A LAPAROSCOPY UNDER FLUOROSCOPY AND WAS ABLE TO LOCATE THE MICRO-INSERT AND REMOVE IT SUCCESSFULLY. THE PATIENT STATES HER PAIN HAS RESOLVED FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS CONCEPTUS, INC. ESS205 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R