BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICON NEOSPHINCTER

    MDR report key: 3113692 · Received May 10, 2013

    Report

    Report Number
    2183959-2013-00820
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 25, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP CATALOG 72402287 - SERIAL # (B)(4), EXP. 04/12/2015, MFG 04/2010; CUFF CATALOG 72401962 - SERIAL # (B)(4), EXP. 09/23/2014, MFG. 09/2009. ANALYSIS RESULTS INDICATE THE BALLOON PRESSURE WAS BELOW SPECIFICATIONS. THE PUMP AND BALLOON PERFORMED WITHIN SPECIFICATIONS. SHOULD ADDITION 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 THE CUFF THAT HAD "MIGRATED ALONG THE ANAL CANAL AND WAS NO LONGER CAUSING OCCLUSION. THE PT WAS LEAKING STOOL." IT WAS ALSO REPORTED THAT THE PT WAS DISSATISFIED AND "FELT CUFF WASN'T OPENING ENOUGH/PROPERLY". THE PHYSICIAN INDICATED THE PT HAD TO STRAIN MORE THAN USUAL WHEN USING THE RESTROOM. THE PT WAS NOT REIMPLANTED AT THIS TIME BECAUSE "A HOLE WAS MADE IN THE RECTUM DURING REMOVAL". "SHE WANTS TO HAVE IMPLANT AGAIN ONCE SHE HEALS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206141 ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER MIP AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R