BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3675247 · Received March 12, 2014

    Report

    Report Number
    3004209178-2014-04328
    Event Type
    Injury
    Date Received
    March 12, 2014
    Report Date
    February 19, 2014
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N143105, IMPLANTED: 2008-(B)(6), PRODUCT TYPE ACCESSORY, PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS REFILLED WHILE SHE WAS HOSPITALIZED FOR PNEUMONIA APPROXIMATELY ONE MONTH PRIOR TO THIS REPORT. THE PRINTOUT WAS NOT RETURNED TO THE HEALTHCARE PROVIDER¿S (HCP) OFFICE AND HER FOLLOW-UP REFILL WAS THEREFORE NOT SCHEDULED, NOR WAS HER MEDICATION ORDERED. ON THE DAY PRIOR TO THIS REPORT, THE HCP WAS NOTIFIED THAT THE PATIENT HAD BEEN HOSPITALIZED AGAIN WITH MENTAL STATUS CHANGES. THE HCP WENT TO REPROGRAM THE PUMP AND REDUCE HER MEDICATION POSSIBLY TO MINIMUM RATE. THE PATIENT¿S MEDICATION WAS ORDERED OVERNIGHT AND SHE WAS TO BE REFILLED IN THE HOSPITAL ON 2014-(B)(6) IF SHE WAS NOT RELEASED AND ABLE TO RETURN TO THE HCP¿S OFFICE. IT WAS INDICATED THAT THERE WAS NO ALLEGED PRODUCT ISSUE. THE DRUG INFORMATION WAS UNAVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147006 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization