BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 3121947 · Received May 15, 2013

    Report

    Report Number
    2183959-2013-00808
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BALLOON: CATALOG 72402105 - SERIAL# (B)(4), EXP 06/04/2012, MFG. 06/2007. PUMP: CATALOG 72402287 - SERIAL # (B)(4), EXP. 07/24/2012, MFG 07/2007. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD HER DEVICE REMOVED DUE TO RECURRING INCONTINENCE. THE PT WAS REIMPLANTED WITH AN ACTICON NEOSPHINCTER DEVICE AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE REASON FOR THE RECURRING INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214507 ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R