BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPS AIM SL

    MDR report key: 3920758 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14348
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DQY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO SLIT THE INNER CATHETER, THE CATHETER TORE WITH THE DISTAL PORTION REMAINING IN THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE AND REMOVE THE REMAINING PORTION OF THE CATHETER. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396932 CPS AIM SL INNER CATHETER DQY ST. JUDE MEDICAL, INC., CRMD DS2N021-59 NA

    Patients

    Seq Age Sex Outcome Treatment
    1