BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENIX CONTINENCE RESTRORATION SYSTEM

    MDR report key: 6123002 · Received November 22, 2016

    Report

    Report Number
    3008766073-2016-00095
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    PMH
    PMA / PMN Number
    H130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED INCONTINENCE (LOSS OF DEVICE EFFECTIVITY) AS A RESULT OF DEVICE EXPOSURE TO AN MRI FIELD LEADING TO FENIX DEVICE EXPLANT. THE FENIX DEVICE WAS USED AS PART OF THE SURGICAL PROCEDURE. UNEVENTFUL SURGICAL PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2016. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2016 DUE TO LOSS OF DEVICE EFFECTIVITY AS A RESULT OF EXPOSURE TO AN MRI FIELD. ALTHOUGH THE FENIX DEVICE IS LABELED AS MRI UNSAFE, THE PATIENT DID NOT REPORT ANY ISSUES DURING OR AFTER THE MRI OTHER THAN LOSS OF DEVICE EFFECTIVITY. IMMEDIATELY AFTER EXPLANT THE PATIENT WAS IMPLANTED WITH A REPLACEMENT FENIX DEVICE. THE DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771978 FENIX CONTINENCE RESTRORATION SYSTEM IMPLANTED FECAL INCONTINENCE DEVICE PMH TORAX MEDICAL, INC. FS15 3736

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O