BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 3881741 · Received June 18, 2014

    Report

    Report Number
    2183959-2014-00231
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    April 30, 2013
    Report Date
    July 10, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT RESOLVED WAS ORIGINALLY REPORTED AS (B)(6) 2013; THE EVENT WAS RESOLVED AS OF (B)(6) 2013.

    Description of Event or Problem · 1

    CORRECTED DATA: THE EVENT WAS RESOLVED AS OF (B)(6) 2013.

    Description of Event or Problem · 1

    RELATED TO MANUFACTURER REPORT #2183959-2013-00984 IT WAS REPORTED THE PATIENT HAD AN ELEVATE PC ANTERIOR AND APICAL PROLAPSE REPAIR SYSTEM IMPLANTED ON (B)(6) 2013. POSTOPERATIVELY, THE PATIENT EXPERIENCED "PELVIC HEMATOMA" AND "ABDOMINAL PAIN, HYPOTA, FEVER." THE PATIENT RECEIVED A BLOOD TRANSFUSION OF 3 UNITS OF BLOOD ON (B)(6) 2013. IT WAS REPORTED THAT THE EVENT WAS SERIOUS AND ONGOING AS OF (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013, INDICATED THE PATIENT HAD A PROLONGED HOSPITAL STAY BUT WAS DISCHARGED AND IS PROGRESSING FAVORABLY. THE PHYSICIAN DETERMINED THAT THE EVENT WAS ASSOCIATED WITH THE PROCEDURE AND NOT THE DEVICE. ADDITIONAL INFORMATION RECEIVED (B)(6) 2013 INDICATED THE PATIENT VISITED THE PHYSICIAN IN (B)(6) AND WAS ASYMPTOMATIC. THERE WERE NO SEQUEL FROM THE REPORTED EVENT. THE PATIENT WILL HAVE A CAT SCAN, AS A CONTROL, IN APPROXIMATELY 3 MONTHS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 INDICATED THE EVENT RESOLVED ON (B)(6) 2013. NOTE: THE "HYPO TA" REPORTED WAS CONFIRMED AS ARTERIAL HYPOTENSION (LOW BLOOD PRESSURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357375 AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MINIARC PRECISE