BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3232963 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11952
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8 731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL . THE REASON FOR THE PATIENT¿S HOSPITAL ADMISSION WAS NOT REPORTED. THEY STATED THAT THEY NEEDED TO TURN THE PAIN PUMP OFF ¿FOR MEDICAL REASONS¿. WHEN ASKED IF THERE WAS SOMETHING GOING ON WITH THE PUMP, THEY STATED ¿YEAH; THAT IT WAS MEDICALLY NECESSARY TO STOP THE MEDICATION". THEY STATED THAT IF THE PUMP COULD BE TURNED OFF IN THE NEXT TWENTY-FOUR HOURS, THEN ¿THE PATIENT WOULD BE OKAY¿. THEY THOUGHT THE MEDICATION USED WITHIN THE SYSTEM WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334073 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R