BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203492 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04548
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    November 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RESPIRATORY FAILURE ATTACK TWO WEEKS AFTER THE PUMP WAS IMPLANTED. THE HEALTH CARE PROVIDER IN THE INTENSIVE CARE UNIT THOUGHT IT WAS RELATED TO THE MEDICATION. THE PATIENT¿S PHYSICIAN THOUGHT THE PATIENT HAD ¿REACTION FROM STUFF THAT THEY SPRAYING IN THE FIELDS.¿ THE PATIENT WAS ALLERGIC TO MORPHINE, BUT WAS TOLD THE MORPHINE REACTED DIFFERENTLY IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302803 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR