BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2040753 · Received March 22, 2011

    Report

    Report Number
    3004209178-2011-02170
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD HERNIA SURGERY AND POST SURGERY; THE PUMP HAD BECOME LOOSE IN THE POCKET. AS A RESULT, THE CATHETER DISCONNECTED FROM THE PUMP. THE PT DID NOT WANT TO HAVE SURGERY TO REVISE THE PUMP AND CATHETER. OPTIONS WERE BEING DISCUSSED WITH THE PT. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR CATHETER: MODEL 8711, LOT# J11147R07| IMPLANTED:| EXPLANTED: