BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 2921553 · Received January 10, 2013

    Report

    Report Number
    2183959-2013-00066
    Event Type
    Death
    Date Received
    January 10, 2013
    Date of Event
    September 4, 2008
    Report Date
    November 28, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K011251
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT AS APPROPRIATE. LAWYER-FILED REPORT - (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THIS WAS SUBMITTED AS A SUPPLEMENTAL REPORT ON THE SUMMARY REPORT DATED (B)(6) 2014 UNDER EXEMPTION (B)(4). ADDITIONALLY, THIS WAS SUBMITTED AS A SUPPLEMENTAL REPORT ON THE SUMMARY REPORT DATED (B)(6) 2015 UNDER EXEMPTION (B)(4). LAWYER-FILED REPORT

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED EMOTIONAL DISTRESS AND A PROBLEM WITH THE PRODUCT. THE DEVICE WAS IMPLANTED FOR TREATMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSES OF DEATH WERE REPORTED AS ACUTE RESPIRATORY FAILURE, ACUTE RENAL FAILURE, INTERNAL HEMORRHAGE, COAGULOPATHY, AND LIVER FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, FISTULAE, RECURRENCE, AND BLEEDING. IT WAS ALSO REPORTED THAT THE PLAINTIFF EXPERIENCED HEMATURIA, STRESS URINARY INCONTINENCE, INTRINSIC SPHINCTER DEFICIENCY, DYSURIA, URINARY FREQUENCY, URINARY URGENCY, NOCTURIA, ODOR IN THE URINE, AND ACUTE CYSTITIS. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15584 SPARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| S BARD TOT SLING | IMPLANTED:| IMPLANTED: