BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201469 · Received July 2, 2013

    Report

    Report Number
    3004209178-2012-10908
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    January 26, 2012
    Report Date
    January 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHILE UPDATING THE IMPLANTABLE INFUSION PUMP, THE TELEMETRY WAS INTERRUPTED. THE PUMP WAS THEN IN STOPPED PUMP MODE. THE HEALTH CARE PROFESSIONAL (HCP) REPROGRAMMED THE PUMP AND RE-UPDATED IT. IT WAS NOTED THAT THE HCP HAD TO RE-ENTER ALL OF THE DATA INTO THE PROGRAMMER. ADDITIONAL INFORMATION STATED THAT THE PATIENT DID NOT HAVE ANY SYMPTOMS. THE PATIENT WAS SENT HOME AFTER HER REFILL AND NOTICED THAT THE PERSONAL THERAPY MANAGER (PTM) WAS NOT ADMINISTERING A BOLUS. THE PATIENT WENT BACK TO THE OFFICE AND IT WAS DISCOVERED THAT THE PTM WAS NOT ENABLED. AFTER ENABLING THE PTM, THE PATIENT WAS DOING ¿FINE.¿ THE DRUG IN THE PUMP WAS DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303416 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR