BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3133673 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08229
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, LOT # N175931002, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOLLOWING A REFILL, THE PERSONAL THERAPY MANAGER (PTM) SHOWED THE REFILL DATE AS (B)(6). THE PHYSICIAN PROGRAMMER DISPLAYED THE REFILL DATE CORRECTLY AS BEING IN (B)(6). ON THE NEXT DAY, IT WAS REPORTED THAT THE PTM WAS DECOUPLED AND RECOUPLED WITH THE PUMP, FOLLOWING SUCH, THE PTM BEGAN WORKING CORRE CTLY. IT WAS UNKNOWN WHAT DRUG WAS USED IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237502 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1