BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032361 · Received March 28, 2011

    Report

    Report Number
    3004209178-2011-02337
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN INFECTION WAS REPORTED. THE PT HAD EXPERIENCED SWELLING AND REDNESS IN A CIRCLE SHAPE OVER THE PUMP FOR ABOUT A WEEK. IT WAS ALSO REPORTED THAT THE PT WAS CONSTIPATED LAST WEEK. AN APPOINTMENT WAS SCHEDULED WITH THE HEALTHCARE PROFESSIONAL. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT PROVIDED. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other EXPLANTED:| CATHETER: MODEL 8703W, LOT# L38431| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8596SC, LOT# N228251007