BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2160644 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05171
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED TO THE EMERGENCY ROOM (B)(6) WITH SIGNS OF WITHDRAWAL. THE PT HAD A PUMP REFILL ON (B)(6) 2011. SHE WAS ADMITTED FOR OBSERVATION AND A MANUFACTURER REP WAS ASKED TO ASSIST IN ADJUSTING HER DOSE LATER IN THE DAY. THE PT'S HEALTH CARE PROVIDER EXPRESSED CONCERN THAT THE MEDICATION IN HER PUMP WAS POSSIBLY "THE WRONG CONCENTRATION." THE PT'S HEALTH CARE PROVIDER DECIDED TO REDUCE HER DOSE TO AND GIVE THE PT ORAL MORPHINE, AND KEEP HER FOR OBSERVATION. IT WAS FURTHER REPORTED THAT THE PT EXPERIENCED DIZZINESS. THE PT'S DRUG WAS COMPOUNDED AT THE PHARMACY AND THE HEALTH CARE PROVIDER SUSPECTED IT MAY HAVE BEEN COMPOUNDED INCORRECTLY. THE PT'S HEALTH CARE PROVIDER WANTED TO REMOVE THE DRUG FROM SYSTEM AND REFILL PUMP WITH NEW DRUG. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS MORPHINE. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED 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 61 YR Hospitalization ACCESSORY: MODEL 8590-1, LOT# N160435| CATHETER: MODEL 8731SC, LOT# N203805018| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: