BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1915144 · Received December 1, 2010

    Report

    Report Number
    3004209178-2010-10076
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED ON (B)(6) 2010. HE EXPERIENCED FEVER, NAUSEA AND VOMITING AT NIGHT AND CONFUSION IN THE MORNING. THE PT WAS SEEN IN THE EMERGENCY ROOM. PER THE REPORTER, AFTER DISCUSSION WITH THE ONCOLOGIST, IT WAS DECIDED TO EXPLANT THE PUMP. THE PUMP WAS EXPLANTED ON (B)(6) 2010. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U 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 72 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N167637004