BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4811800 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-10090
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(4) 2003, PRODUCT TYPE: CATHETER. PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR PUMP HAD BEEN PROGRAMMED WRONG. THE REFILL DATE WAS ONLY A MONTH AND IT USUALLY WAS 4 MONTHS. THE PATIENT DID NOT KNOW WHAT WAS PROGRAMMED INCORRECTLY. THE PATIENT STATED THAT THEY WERE INSTRUCTED BY THE HCP¿S OFFICE TO CALL AND HAVE SOMEONE COME OUT TO THEIR HOUSE TO REPROGRAM THEIR PUMP. NO SYMPTOMS, INTERVENTIONS OR DRUG REPORTED. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355758 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR